FDA Browser
by
Innolitics
Anesthesiology
Review Panel
Miscellaneous
Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
CFR Sub-Part
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart C—Cardiovascular Monitoring Devices
CFR Sub-Part
Subpart C—Monitoring Devices
CFR Sub-Part
Subpart D—Prosthetic Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
Subpart F—Cardiovascular Therapeutic Devices
CFR Sub-Part
Subpart F—Neurological Therapeutic Devices
CFR Sub-Part
Subpart F—Physical Medicine Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
BRW
Protector, Dental
1
Product Code
BSF
Absorber, Carbon-Dioxide
1
Product Code
BSJ
Mask, Gas, Anesthetic
1
Product Code
BSK
Cuff, Tracheal Tube, Inflatable
2
Product Code
BSN
Filter, Conduction, Anesthetic
2
Product Code
BSO
Catheter, Conduction, Anesthetic
2
Product Code
BSP
Needle, Conduction, Anesthetic (W/Wo Introducer)
2
Product Code
BSR
Stylet, Tracheal Tube
1
Product Code
BSZ
Gas-Machine, Anesthesia
2
Product Code
BTB
Hook, Ether
1
Product Code
BTC
Bag, Reservoir
1
Product Code
BTK
Strap, Head, Gas Mask
1
Product Code
BTL
Ventilator, Emergency, Powered (Resuscitator)
2
Product Code
BTM
Ventilator, Emergency, Manual (Resuscitator)
2
Product Code
BTO
Tube, Tracheostomy (W/Wo Connector)
2
Product Code
BTP
Dropper, Ether
1
Product Code
BTQ
Airway, Nasopharyngeal
1
Product Code
BTR
Tube, Tracheal (W/Wo Connector)
2
Product Code
BTS
Tube, Bronchial (W/Wo Connector)
2
Product Code
BTT
Humidifier, Respiratory Gas, (Direct Patient Interface)
2
Product Code
BWB
Forceps, Tube Introduction
1
Product Code
BWC
Needle, Emergency Airway
2
Product Code
BWF
Spirometer, Therapeutic (Incentive)
2
Product Code
BWL
Apparatus, Electronanesthesia
3
Product Code
BYD
Condenser, Heat And Moisture (Artificial Nose)
1
Product Code
BYE
Attachment, Breathing, Positive End Expiratory Pressure
2
Product Code
BYF
Mask, Oxygen, Low Concentration, Venturi
1
Product Code
BYG
Mask, Oxygen
1
Product Code
BYH
Drain, Tee (Water Trap)
1
Product Code
BYI
Percussor, Powered-Electric
2
Product Code
BYJ
Unit, Liquid-Oxygen, Portable
2
Product Code
BYK
Tent, Oxygen, Electrically Powered
2
Product Code
BYL
Tent, Oxygen
1
Product Code
BYN
Chair, Posture, For Cardiac And Pulmonary Treatment
1
Product Code
BYO
Bottle, Blow
1
Product Code
BYP
Mouthpiece, Breathing
1
Product Code
BYT
Ventilator, External Body, Negative Pressure, Adult (Cuirass)
2
Product Code
BYW
Device, Rebreathing
1
Product Code
BYX
Tubing, Pressure And Accessories
1
Product Code
BZA
Connector, Airway (Extension)
1
Product Code
BZB
Catheter, Nasal, Oxygen
1
Product Code
BZD
Ventilator, Non-Continuous (Respirator)
2
Product Code
BZE
Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
2
Product Code
BZO
Set, Tubing And Support, Ventilator (W Harness)
1
Product Code
BZR
Mixer, Breathing Gases, Anesthesia Inhalation
2
Product Code
CAD
Vaporizer, Anesthesia, Non-Heated
2
Product Code
CAE
Airway, Oropharyngeal, Anesthesiology
1
Product Code
CAF
Nebulizer (Direct Patient Interface)
2
Product Code
CAG
Circulator, Breathing-Circuit
2
Product Code
CAI
Circuit, Breathing (W Connector, Adaptor, Y Piece)
1
Product Code
CAL
Laryngoscope, Non-Rigid
1
Product Code
CAO
Airway, Esophageal (Obturator)
2
Product Code
CAT
Cannula, Nasal, Oxygen
1
Product Code
CAW
Generator, Oxygen, Portable
2
Product Code
CAZ
Anesthesia Conduction Kit
2
Product Code
K
22
2341
Arrow 0.2 Micron Flat Filter, GVS
2
Cleared 510(K)
K
21
0983
BD Epilor Syringe
2
Cleared 510(K)
K
20
1356
Plastic LOR Syringe
2
Cleared 510(K)
K
20
2699
E-Cath STIM acc. Tsui
2
Cleared 510(K)
K
19
0345
VPC
2
Cleared 510(K)
K
16
1075
Arrow Epidural Catheter Kit
2
Cleared 510(K)
K
15
3652
ARROW FlexBlock Continuous Peripheral Nerve Block Catheter Kit/Set
2
Cleared 510(K)
K
14
3581
Arrow Epidural Catheter Kit
2
Cleared 510(K)
K
12
2690
ULTRAQUIK PERIPHERAL NERVE BLOCK NEEDLE
2
Cleared 510(K)
K
11
0053
CORRECTINJECT SAFETY SYSTEM, CATHETER CONNECTOR, FILTER, INFUSION ADAPTOR, SYRINGE KIT
2
Cleared 510(K)
K
12
2027
ARROW FLEXBLOCK CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER
2
Cleared 510(K)
K
12
1525
PERIFUSE CATHETER
2
Cleared 510(K)
K
12
1403
CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER KIT AND SET
2
Cleared 510(K)
K
10
3658
FLEXTIP PLUS CLOSED TIP EPIDURAL CATHERTER
2
Cleared 510(K)
K
11
3662
FENESTRATED NERVE BLOCK NEEDLE
2
Cleared 510(K)
K
11
3188
SONOLONG SONO, CURL SONO, NANOLINE, BRAND NAMES CARRYINGSONO/SONOLONG
2
Cleared 510(K)
K
11
3059
CONTIPLEX FX
2
Cleared 510(K)
K
11
1355
ECHOBRIGHT
2
Cleared 510(K)
K
10
2007
PROLONG, MODELS PL 18040TC, PL18050TGC, PL18100TGC, PL18150TGC,
2
Cleared 510(K)
K
09
3662
ECHOBRIGHT
2
Cleared 510(K)
K
09
2657
EPIFUSE CATHETER CONNECTOR, MODEL: 4909E
2
Cleared 510(K)
K
09
0995
B. BRAUN CONTIPLEX CONTINUOUS NERVE BLOCK SET
2
Cleared 510(K)
K
08
2183
PAJUNK'S GENERIC CONVENIENCE TRAY FOR REGIONAL ANESTHESIA: CSF
2
Cleared 510(K)
K
08
2164
PAJUNK'S GENERIC CONVENIENCE TRAY FOR REGIONAL ANESTHESIA OF THE PERIPHERAL PLEXUS: SINGLE SHOT
2
Cleared 510(K)
K
08
0804
BUSSE PLASTIC LOR SYRINGE
2
Cleared 510(K)
K
07
3187
PERIPHERAL NERVE BLOCK SUPPORT TRAY
2
Cleared 510(K)
K
06
3282
CONTIPLEX STIM CONTINUOUS NERVE BLOCK SET
2
Cleared 510(K)
K
06
2902
PAJUNKS EPILONG SET PEDIATRIC
2
Cleared 510(K)
K
06
3018
GLASS LOSS OF RESISTANCE SYRINGE
2
Cleared 510(K)
K
06
2900
PAJUNKS STIMULONG TSUI-METHOD SET
2
Cleared 510(K)
K
06
1737
LOSS OF RESISTANCE SYRINGE
2
Cleared 510(K)
K
06
0186
POLYPLEX STIMULATING CATHETER SYSTEM
2
Cleared 510(K)
K
06
0311
EPILONG KIT FOR ANESTHESIOLOGY
2
Cleared 510(K)
K
06
0563
EPISPIN, EPISPIN II SAFETY, EPISPIN II, EPISPIN I, EPISPIN IV
2
Cleared 510(K)
K
05
2954
CONTISTIM CONTINUOUS STIMULATING CATHETER NERVE BLOCK SET
2
Cleared 510(K)
K
05
3283
UNIPLEX NANOLINE CANNULA, PLEXOLONG NANOLINE SET, STIMULONG NANOLINE SET
2
Cleared 510(K)
K
05
2946
MPS ACACIA NERVE BLOCK NEEDLE
2
Cleared 510(K)
K
05
1171
STINGRAY EPIDURAL CATHETER CONNECTOR
2
Cleared 510(K)
K
04
3130
MODIFICATION TO PAJUNK STIMULONG PLUS CATHETER SETS
2
Cleared 510(K)
K
04
1158
ATRION EPIDURAL ANESTHESIA KIT WITH ATRION NEEDLEVISE SHARPS SECURING SYSTEM
2
Cleared 510(K)
K
03
3018
STIMULONG PLUS CATHETER SET MODEL, VARIOUS
2
Cleared 510(K)
K
03
3080
PORTEX 24G PEDIATRIC EPIDURAL AND PERIPHERAL BLOCK ANESTHESIA CATHETER
2
Cleared 510(K)
K
03
3952
PERIFIX CATHETER CONNECTOR
2
Cleared 510(K)
K
03
1128
B-SMART, MODEL B-01
2
Cleared 510(K)
K
03
2144
PERIFIX CATHETER CONNECTOR
2
Cleared 510(K)
K
02
2752
PANDIN CONTINUOUS NERVE STIMULATING CATHETER, MODELS 561-18-05, 561-18-09, 561-18-15, 562-18-05, 562-18-09 & 562-18-15
2
Cleared 510(K)
K
03
0937
STIMUCATH CONTINUOUS NERVE BLOCK SET, MODELS AB-02030, AB-02060, AB-02090, AB-02030-PK, AB-02060-PK, AB-02090-PK
2
Cleared 510(K)
K
01
4246
AVID-NIT NERVE STIMULATION NEEDLES
2
Cleared 510(K)
K
02
1567
STIMUCATH CONTINUOUS NERVE BLOCK SET, PRODUCT NUMBER AB-05000
2
Cleared 510(K)
K
01
3041
PLEXOLONG SETS
2
Cleared 510(K)
K
01
2584
MODIFICATION TO: BD DURASAFE PLUS EPIDURAL LOCK CSE NEEDLE SET/KIT
2
Cleared 510(K)
K
99
4059
CLA KIT (CONTINUOUS LOCAL ANESTHESIA), MODEL 551-17, 551-10, 551-07
2
Cleared 510(K)
K
00
1940
MICOR ANESTHESIA CONDUCTION KIT
2
Cleared 510(K)
K
00
1587
19 GA PLASTIC REINFORCED EPIDURAL CATHETER
2
Cleared 510(K)
K
00
1129
PROLONG, MODELS PL50, PL100, PL150
2
Cleared 510(K)
K
99
1719
EPISTAR/EPISTAR CSE SPINAL/EPIDURAL ANESTHESIA ADMINISTRATION SETS
2
Cleared 510(K)
K
98
3125
EPIDURAL CATHETER MODELS 1210/1200
2
Cleared 510(K)
K
97
1233
SOFT TIP EPIDURAL CATHETER KIT
2
Cleared 510(K)
K
96
2696
PERIFIX PEDIATRIC EPIDURAL KIT
2
Cleared 510(K)
K
96
5017
REGIONAL ANESTHESIA TRAYS
2
Cleared 510(K)
K
96
4783
EPIDURAL MINI KIT, ELDOR COMBINED SPINAL/EPIDURAL KIT
2
Cleared 510(K)
K
96
2880
SENSI-TOUCH COMBO SPINAL/EPIDURAL REGIONAL ANESTHESIA DELIVERY SYSTEM
2
Cleared 510(K)
K
96
2821
EPIDURAL ANESTHESIA KIT AND COMBINED SPINAL EPIDURAL ANESTHESIA KIT
2
Cleared 510(K)
K
96
1075
MEDCARE REGIONAL ANETHESIA KIT
2
Cleared 510(K)
K
96
0619
MORE-L INJECTOR KIT PLUS
2
Cleared 510(K)
K
95
4706
KENDALL BLUNT TUOHY EPIDURAL NEEDLE
2
Cleared 510(K)
K
95
4953
B-D DURASAFE COMBINED SPINAL EPIDURAL (CSE) TRAY
2
Cleared 510(K)
K
96
0100
SPINAL SPECIALTIES NERVE BLOCK TRAY
2
Cleared 510(K)
K
95
4835
HOLGRATH COMBINED SPINAL EPIDURAL NEEDLE SET
2
Cleared 510(K)
K
95
1870
MORELL INJECTOR
2
Cleared 510(K)
K
95
3790
BD PERISAFE EPIDURAL ANESTHESIA TRAY
2
Cleared 510(K)
K
95
3766
KENDALL SAFETAP SPINAL ANESTHESIA TRAY
2
Cleared 510(K)
K
95
3467
B-D SPINAL ANESTHESIA TRAY SPINAL
2
Cleared 510(K)
K
94
4029
CONTINUOUS EPIDURAL ANESTHESIA TRAY
2
Cleared 510(K)
K
94
3319
GERTIE MARX EPI-SPINAL TRAY
2
Cleared 510(K)
K
94
5484
PIDURAL STEROID SYSTEM
2
Cleared 510(K)
K
95
0929
SENSI-TOUCH EPIDURAL ANESTHESIA TRAY
2
Cleared 510(K)
K
94
1153
EPI-SPINAL ANESTHESIA TRAY
2
Cleared 510(K)
K
94
5671
CONTINUOUS EPIDURAL ANESTHESIA TRAY
2
Cleared 510(K)
K
94
5497
B-D DURASAFE)TM) VARIABLE EXTENSION COMBINED SPINAL EPIDURAL *CSE) NEEDLE SET/KIT
2
Cleared 510(K)
K
93
2614
REGIONAL ANAESTHESIA TRAY
2
Cleared 510(K)
K
94
1343
SPINAL ANESTHESIA TRAY
2
Cleared 510(K)
K
94
1493
KENDALL SAFETRAK COMBINED EPIDURAL/SPINAL KIT
2
Cleared 510(K)
K
93
5245
EPIDURAL ANESTHESIA TRAY
2
Cleared 510(K)
K
93
3721
EPIDURAL ANESTHESIA PROCEDURE TRAY, CUSTOM
2
Cleared 510(K)
K
93
4526
MICRO-SP CUSTOM SPINAL ANESTHESIA TRAY
2
Cleared 510(K)
K
93
1670
CARAPACE EPIDURAL BLOCK & SPINAL MYELOGRAM TRAYS
2
Cleared 510(K)
K
93
3711
E-SP COMBINED EPIDURAL-SPINAL ANESTHESIA TRAY
2
Cleared 510(K)
K
93
2249
DURASAFE B-D COMBINED SPINAL EPIDURAL ANESTHESIA
2
Cleared 510(K)
K
93
0161
ANAGO SPINAL ANESTHESIA TRAY
2
Cleared 510(K)
K
92
4707
VARIOUS ANESTHETIC KITS OR TRAYS
2
Cleared 510(K)
K
92
5014
E-SP COMBINED EPI SPINAL MINISET
2
Cleared 510(K)
K
92
2162
CURITY PLASTIC LOSS OF RESISTANCE SYRINGE
2
Cleared 510(K)
K
92
0615
ANAGO CONTINUOUS EPIDURAL ANESTHESIA TRAY/KIT
2
Cleared 510(K)
K
92
5902
B-D LOSS OF RESISTANCE SYRINGE
2
Cleared 510(K)
K
91
2445
MEGA CONTINUOUS EPIDURAL ANESTHESIA KIT
2
Cleared 510(K)
K
91
2322
MEGA SPINAL ANESTHESIA KIT
2
Cleared 510(K)
K
90
4440
LOCAL PLEXUS BLOCK ANESTHESIA CATHETER KITS
2
Cleared 510(K)
K
90
3761
CURITY SPINAL ANESTHESIA TRAY
2
Cleared 510(K)
K
90
4101
COSPAN CONTINUOUS SPINAL ANESTHESIA TRAY
2
Cleared 510(K)
K
90
3887
CURITY NERVE BLOCK TRAY
2
Cleared 510(K)
K
90
2647
CURITY PEDIATRIC CONTINUOUS CAUDAL ANESTHESIA TRAY
2
Cleared 510(K)
K
90
2312
COSPAN PEDIATRIC CONTINUOUS SPINAL ANESTHESIA TRAY
2
Cleared 510(K)
K
89
6799
PARACERVICAL/PUDENDAL TRAYS
2
Cleared 510(K)
K
89
5955
LOPER CELIAC PLEXUS BLOCK CATHETER KIT
2
Cleared 510(K)
K
89
5476
OPTION EPIDURAL CATHETERS
2
Cleared 510(K)
K
89
6392
MEDTRONIC EPIDURAL CATHETER KIT MODEL 8717
2
Cleared 510(K)
K
89
4725
MEDIZIV EPIDURAL SYSTEMS
2
Cleared 510(K)
K
89
5192
SPINOCAN(R) CONTINUOUS SPINAL TRAY
2
Cleared 510(K)
K
89
2660
HIBERNATION KIT
2
Cleared 510(K)
K
89
3938
CONTINUOUS EPIDURAL ANESTHESIA TRAY
2
Cleared 510(K)
K
89
1281
INTERPLEURAL ANESTHESIA KIT W/POLYURETHANE CATH.
2
Cleared 510(K)
K
89
0732
MEDSURG EPIDURAL TRAY/BULLET TIP/17 GA TUOHY 1002E
2
Cleared 510(K)
K
89
0733
MEDSURG EPIDURAL TRAY/19 GAGE OPEN END TUOHY 1012
2
Cleared 510(K)
K
89
0731
MEDSURG EPIDURAL TRAY/19 GA/BUL TIP/17GA TUO 1002
2
Cleared 510(K)
K
89
0730
MEDSURG EPIDURAL TRAY 19 GAGE/ECON/BULLET TIP 1000
2
Cleared 510(K)
K
88
5278
EPIDURAL ANESTHESIA TRAY
2
Cleared 510(K)
K
88
4552
CONTINUOUS EPIDURAL ANESTHESIA KIT W/POLY CATHETER
2
Cleared 510(K)
K
88
5277
SPINAL ANESTHESIA TRAY
2
Cleared 510(K)
K
88
5238
CURITY CONTINUOUS SPINAL ANESTHESIA TRAY
2
Cleared 510(K)
K
88
3314
PMT 3721-1 EPIDURAL KIT
2
Cleared 510(K)
K
88
2394
MEDTRONIC EPIDURAL CATHETER KIT MODEL 8716
2
Cleared 510(K)
K
88
1429
YANKAUER SUCTION INSTRU./LAYTEX GLOVES/SUCT. CATH.
2
Cleared 510(K)
K
88
0970
AXILLARY BLOCK NEEDLE
2
Cleared 510(K)
K
87
4674
AIK-100 ANESTHESIA INDUCTION KIT/TRAY
2
Cleared 510(K)
K
88
0181
REGANES DISPOSABLE EPIDURAL ANESTHESIA TRAY
2
Cleared 510(K)
K
87
4105
BRACHIAL PLEXUS CATHETER - BP-01200
2
Cleared 510(K)
K
87
3943
CONTINUOUS EPIDURAL ANESTH. KITS W/NYLON CATHETERS
2
Cleared 510(K)
K
87
1066
CURITY CONTINUOUS EPIDURAL ANESTHESIA TRAY
2
Cleared 510(K)
K
86
0833
EPIDURAL ANESTHESIA TRAY
2
Cleared 510(K)
K
85
4518
EPIDURAL ANESTHESIA TRAY
2
Cleared 510(K)
K
85
1134
REGIONAL ANESTHESIA TRAYS
2
Cleared 510(K)
K
85
1479
VYGON BALLOON FOR IDENTIFICATION OF EPIDURAL 193
2
Cleared 510(K)
K
84
4982
VAS-CATH CONTINOUS EPIDURAL ANESTH. CATH/KIT/TRAY
2
Cleared 510(K)
K
84
2095
EPIDURAL TRAYS
2
Cleared 510(K)
K
84
0179
CONTINUOUS EPIDURAL ANESTHES. TRAY
2
Cleared 510(K)
K
84
0287
BRACHIAL PLEXUS ANESTHESIA TRAY
2
Cleared 510(K)
K
83
2778
EPIDURAL SYRINGE
2
Cleared 510(K)
K
82
2691
VYGON EPIDURAL ANAESTHESIA TRAY
2
Cleared 510(K)
K
81
3186
PERFIX SET FOR EPIDURAL ANESTHESIA W/TUO
2
Cleared 510(K)
K
80
2290
REGIONAL INTRAVENOUS ANESTHESIA KIT
2
Cleared 510(K)
K
80
1912
ARROW POSITIVE PLACEMENT CON/EPIDURAL AN
2
Cleared 510(K)
K
80
1724
CURITY PARACERVICAL/PUDENDAL BLOCK ANES
2
Cleared 510(K)
K
78
1469
POSITIVE PLACEMENT ANETHESIA KIT
2
Cleared 510(K)
K
78
2069
TRAY, AUXILLARY BLOCK
2
Cleared 510(K)
K
78
1052
CONTINUOUS EPIDURAL ANESTHESIA TRAY
2
Cleared 510(K)
K
78
0120
ANESTHESIA TRAY, CAUDAL
2
Cleared 510(K)
K
77
0571
TRAY, ANESTHESIA, EPIDURAL, CONTINUOUS
2
Cleared 510(K)
K
77
0461
ANESTHESIA KIT, EPIDURAL BLOCK, CONTINU.
2
Cleared 510(K)
K
77
0356
ANESTHESIA KIT, EPIDURAL, SINGLE SHOT
2
Cleared 510(K)
K
77
0096
EPIDURAL BLOCK PROCEDURE PACK
2
Cleared 510(K)
K
76
1162
BRACHIAL PLEXUS BLOCK ANESTHESIA KIT
2
Cleared 510(K)
K
76
0352
CIRCUIT, INTENSIVE CARE VENTILATOR
2
Cleared 510(K)
K
76
0343
TRAY, CURITY CONTINUOUS EPIDURAL
2
Cleared 510(K)
K
76
0249
TRAY, STERILE DISPOSABLE ARTHROGRAM
2
Cleared 510(K)
CBF
Chamber, Hyperbaric
2
Product Code
CBG
Spreader, Cuff
1
Product Code
CBH
Device, Fixation, Tracheal Tube
1
Product Code
CBI
Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
2
Product Code
CBK
Ventilator, Continuous, Facility Use
2
Product Code
CBL
Absorbent, Carbon-Dioxide
1
Product Code
CBN
Apparatus, Gas-Scavenging
2
Product Code
CBO
Attachment, Intermittent Mandatory Ventilation (Imv)
2
Product Code
CBP
Valve, Non-Rebreathing
2
Product Code
MOD
Accessory To Continuous Ventilator (Respirator)
2
Product Code
CCO
Bed, Rocking, Breathing Assist
2
Product Code
CCQ
Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
1
Product Code
CCT
Applicator (Laryngo-Tracheal), Topical Anesthesia
2
Product Code
CCW
Laryngoscope, Rigid
1
Product Code
EPE
Brush, Cleaning, Tracheal Tube
1
Product Code
FNC
Tent, Pediatric Aerosol
2
Product Code
FOG
Hood, Oxygen, Infant
1
Product Code
JAY
Support, Breathing Tube
1
Product Code
JOH
Tube Tracheostomy And Tube Cuff
2
Product Code
KFZ
Humidifier, Non-Direct Patient Interface (Home-Use)
1
Product Code
KGB
Mask, Oxygen, Non-Rebreathing
1
Product Code
KHA
Mask, Scavenging
1
Product Code
LNZ
Changer, Tube, Endotracheal
2
Product Code
MIA
Needle, Spinal, Short Term
2
Product Code
MNS
Ventilator, Continuous, Non-Life-Supporting
2
Product Code
MNT
Ventilator, Continuous, Minimal Ventilatory Support, Facility Use
2
Product Code
MRN
Apparatus, Nitric Oxide Delivery
2
Product Code
MRO
Apparatus, Nitric Oxide, Backup Delivery
2
Product Code
MZT
Device, Heimlich Maneuver Assist
2
Product Code
NFB
Conserver, Oxygen
2
Product Code
NHJ
Device, Positive Pressure Breathing, Intermittent
2
Product Code
NHK
Resuscitator, Manual, Non Self-Inflating
2
Product Code
NMA
Tube, Tracheal, Reprocessed
2
Product Code
NMC
Mask, Ventilator, Non-Continuous, Reprocessed
2
Product Code
NMR
Needle, Spinal, Short Term, Reprocessed
2
Product Code
NNH
Needle, Conduction, Anesthesia, Reprocessed
2
Product Code
NOU
Continuous, Ventilator, Home Use
2
Product Code
NQY
Ventilator, Continuous, Minimal Ventilatory Support, Home Use
2
Product Code
NVO
Spacer, Direct Patient Interface
2
Product Code
NVP
Holding Chambers, Direct Patient Interface
2
Product Code
NXA
Tracheotomy Care Kit
2
Product Code
OBN
Humidifier, Respiratory, Mask (Direct Patient Interface)
2
Product Code
OFQ
Anesthesia Kit
2
Product Code
OFT
Spinal Epidural Anesthesia Kit
2
Product Code
OFU
Spinal Anesthesia Kit
2
Product Code
OFV
Regional Anesthesia Kit
2
Product Code
OGA
Brachial Plexus Anesthesia Kit
2
Product Code
OGB
Caudal Anesthesia Kit
2
Product Code
OGC
Continuous Brachial Plexus Block Tray
2
Product Code
OGD
Custom Anesthesia Tray
2
Product Code
OGE
Epidural Anesthesia Kit
2
Product Code
OGF
Glossopharyngeal Anesthesia Kit
2
Product Code
OGG
Humidifier Nebulizer Kit
2
Product Code
OGH
Laryngoscope Kit
1
Product Code
OGI
Nasal Endotracheal Tube Holder Kit
1
Product Code
OGJ
Nerve Block Tray
2
Product Code
OGL
Oxygen Administration Kit
2
Product Code
OLF
Medevac Use Oxygen Generator
2
Product Code
ONZ
Mechanical Ventilator
2
Product Code
OQU
Airway Monitoring System
2
Product Code
PHS
Oral Airway Assist
1
Product Code
PMB
External Airway
2
Product Code
QAV
High Flow/High Velocity Humidified Oxygen Delivery Device
2
Product Code
QBY
Positive Airway Pressure System
2
Product Code
QCX
Retrograde Intubation Set
2
Product Code
OZR
Intraoral Pressure Gradient Device
2
Product Code
QFB
Isocapnic Ventilation Device
2
Product Code
Subpart G—Miscellaneous
CFR Sub-Part
Cardiovascular
Review Panel
Chemistry
Review Panel
Dental
Review Panel
Ear, Nose, Throat
Review Panel
Gastroenterology and Urology
Review Panel
General Hospital
Review Panel
Hematology
Review Panel
Immunology
Review Panel
Microbiology
Review Panel
Neurology
Review Panel
Obstetrical and Gynecological
Review Panel
Ophthalmic
Review Panel
Orthopedic
Review Panel
Pathology
Review Panel
Physical Medicine
Review Panel
Radiology
Review Panel
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 13 December 2024 at 11:05 pm
AN
/
subpart-f—therapeutic-devices
/
CAZ
/
K111355
View Source
ECHOBRIGHT
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K111355
510(k) Type
Special
Applicant
LIFE-TECH, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/16/2011
Days to Decision
123 days
Submission Type
Statement
FDA Browser
by
Innolitics
Anesthesiology
Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
Subpart B—Diagnostic Devices
Subpart C—Cardiovascular Monitoring Devices
Subpart C—Monitoring Devices
Subpart D—Prosthetic Devices
Subpart E—Surgical Devices
Subpart F—Cardiovascular Therapeutic Devices
Subpart F—Neurological Therapeutic Devices
Subpart F—Physical Medicine Therapeutic Devices
Subpart F—Therapeutic Devices
BRW
Protector, Dental
BSF
Absorber, Carbon-Dioxide
BSJ
Mask, Gas, Anesthetic
BSK
Cuff, Tracheal Tube, Inflatable
BSN
Filter, Conduction, Anesthetic
BSO
Catheter, Conduction, Anesthetic
BSP
Needle, Conduction, Anesthetic (W/Wo Introducer)
BSR
Stylet, Tracheal Tube
BSZ
Gas-Machine, Anesthesia
BTB
Hook, Ether
BTC
Bag, Reservoir
BTK
Strap, Head, Gas Mask
BTL
Ventilator, Emergency, Powered (Resuscitator)
BTM
Ventilator, Emergency, Manual (Resuscitator)
BTO
Tube, Tracheostomy (W/Wo Connector)
BTP
Dropper, Ether
BTQ
Airway, Nasopharyngeal
BTR
Tube, Tracheal (W/Wo Connector)
BTS
Tube, Bronchial (W/Wo Connector)
BTT
Humidifier, Respiratory Gas, (Direct Patient Interface)
BWB
Forceps, Tube Introduction
BWC
Needle, Emergency Airway
BWF
Spirometer, Therapeutic (Incentive)
BWL
Apparatus, Electronanesthesia
BYD
Condenser, Heat And Moisture (Artificial Nose)
BYE
Attachment, Breathing, Positive End Expiratory Pressure
BYF
Mask, Oxygen, Low Concentration, Venturi
BYG
Mask, Oxygen
BYH
Drain, Tee (Water Trap)
BYI
Percussor, Powered-Electric
BYJ
Unit, Liquid-Oxygen, Portable
BYK
Tent, Oxygen, Electrically Powered
BYL
Tent, Oxygen
BYN
Chair, Posture, For Cardiac And Pulmonary Treatment
BYO
Bottle, Blow
BYP
Mouthpiece, Breathing
BYT
Ventilator, External Body, Negative Pressure, Adult (Cuirass)
BYW
Device, Rebreathing
BYX
Tubing, Pressure And Accessories
BZA
Connector, Airway (Extension)
BZB
Catheter, Nasal, Oxygen
BZD
Ventilator, Non-Continuous (Respirator)
BZE
Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
BZO
Set, Tubing And Support, Ventilator (W Harness)
BZR
Mixer, Breathing Gases, Anesthesia Inhalation
CAD
Vaporizer, Anesthesia, Non-Heated
CAE
Airway, Oropharyngeal, Anesthesiology
CAF
Nebulizer (Direct Patient Interface)
CAG
Circulator, Breathing-Circuit
CAI
Circuit, Breathing (W Connector, Adaptor, Y Piece)
CAL
Laryngoscope, Non-Rigid
CAO
Airway, Esophageal (Obturator)
CAT
Cannula, Nasal, Oxygen
CAW
Generator, Oxygen, Portable
CAZ
Anesthesia Conduction Kit
K
22
2341
Arrow 0.2 Micron Flat Filter, GVS
K
21
0983
BD Epilor Syringe
K
20
1356
Plastic LOR Syringe
K
20
2699
E-Cath STIM acc. Tsui
K
19
0345
VPC
K
16
1075
Arrow Epidural Catheter Kit
K
15
3652
ARROW FlexBlock Continuous Peripheral Nerve Block Catheter Kit/Set
K
14
3581
Arrow Epidural Catheter Kit
K
12
2690
ULTRAQUIK PERIPHERAL NERVE BLOCK NEEDLE
K
11
0053
CORRECTINJECT SAFETY SYSTEM, CATHETER CONNECTOR, FILTER, INFUSION ADAPTOR, SYRINGE KIT
K
12
2027
ARROW FLEXBLOCK CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER
K
12
1525
PERIFUSE CATHETER
K
12
1403
CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER KIT AND SET
K
10
3658
FLEXTIP PLUS CLOSED TIP EPIDURAL CATHERTER
K
11
3662
FENESTRATED NERVE BLOCK NEEDLE
K
11
3188
SONOLONG SONO, CURL SONO, NANOLINE, BRAND NAMES CARRYINGSONO/SONOLONG
K
11
3059
CONTIPLEX FX
K
11
1355
ECHOBRIGHT
K
10
2007
PROLONG, MODELS PL 18040TC, PL18050TGC, PL18100TGC, PL18150TGC,
K
09
3662
ECHOBRIGHT
K
09
2657
EPIFUSE CATHETER CONNECTOR, MODEL: 4909E
K
09
0995
B. BRAUN CONTIPLEX CONTINUOUS NERVE BLOCK SET
K
08
2183
PAJUNK'S GENERIC CONVENIENCE TRAY FOR REGIONAL ANESTHESIA: CSF
K
08
2164
PAJUNK'S GENERIC CONVENIENCE TRAY FOR REGIONAL ANESTHESIA OF THE PERIPHERAL PLEXUS: SINGLE SHOT
K
08
0804
BUSSE PLASTIC LOR SYRINGE
K
07
3187
PERIPHERAL NERVE BLOCK SUPPORT TRAY
K
06
3282
CONTIPLEX STIM CONTINUOUS NERVE BLOCK SET
K
06
2902
PAJUNKS EPILONG SET PEDIATRIC
K
06
3018
GLASS LOSS OF RESISTANCE SYRINGE
K
06
2900
PAJUNKS STIMULONG TSUI-METHOD SET
K
06
1737
LOSS OF RESISTANCE SYRINGE
K
06
0186
POLYPLEX STIMULATING CATHETER SYSTEM
K
06
0311
EPILONG KIT FOR ANESTHESIOLOGY
K
06
0563
EPISPIN, EPISPIN II SAFETY, EPISPIN II, EPISPIN I, EPISPIN IV
K
05
2954
CONTISTIM CONTINUOUS STIMULATING CATHETER NERVE BLOCK SET
K
05
3283
UNIPLEX NANOLINE CANNULA, PLEXOLONG NANOLINE SET, STIMULONG NANOLINE SET
K
05
2946
MPS ACACIA NERVE BLOCK NEEDLE
K
05
1171
STINGRAY EPIDURAL CATHETER CONNECTOR
K
04
3130
MODIFICATION TO PAJUNK STIMULONG PLUS CATHETER SETS
K
04
1158
ATRION EPIDURAL ANESTHESIA KIT WITH ATRION NEEDLEVISE SHARPS SECURING SYSTEM
K
03
3018
STIMULONG PLUS CATHETER SET MODEL, VARIOUS
K
03
3080
PORTEX 24G PEDIATRIC EPIDURAL AND PERIPHERAL BLOCK ANESTHESIA CATHETER
K
03
3952
PERIFIX CATHETER CONNECTOR
K
03
1128
B-SMART, MODEL B-01
K
03
2144
PERIFIX CATHETER CONNECTOR
K
02
2752
PANDIN CONTINUOUS NERVE STIMULATING CATHETER, MODELS 561-18-05, 561-18-09, 561-18-15, 562-18-05, 562-18-09 & 562-18-15
K
03
0937
STIMUCATH CONTINUOUS NERVE BLOCK SET, MODELS AB-02030, AB-02060, AB-02090, AB-02030-PK, AB-02060-PK, AB-02090-PK
K
01
4246
AVID-NIT NERVE STIMULATION NEEDLES
K
02
1567
STIMUCATH CONTINUOUS NERVE BLOCK SET, PRODUCT NUMBER AB-05000
K
01
3041
PLEXOLONG SETS
K
01
2584
MODIFICATION TO: BD DURASAFE PLUS EPIDURAL LOCK CSE NEEDLE SET/KIT
K
99
4059
CLA KIT (CONTINUOUS LOCAL ANESTHESIA), MODEL 551-17, 551-10, 551-07
K
00
1940
MICOR ANESTHESIA CONDUCTION KIT
K
00
1587
19 GA PLASTIC REINFORCED EPIDURAL CATHETER
K
00
1129
PROLONG, MODELS PL50, PL100, PL150
K
99
1719
EPISTAR/EPISTAR CSE SPINAL/EPIDURAL ANESTHESIA ADMINISTRATION SETS
K
98
3125
EPIDURAL CATHETER MODELS 1210/1200
K
97
1233
SOFT TIP EPIDURAL CATHETER KIT
K
96
2696
PERIFIX PEDIATRIC EPIDURAL KIT
K
96
5017
REGIONAL ANESTHESIA TRAYS
K
96
4783
EPIDURAL MINI KIT, ELDOR COMBINED SPINAL/EPIDURAL KIT
K
96
2880
SENSI-TOUCH COMBO SPINAL/EPIDURAL REGIONAL ANESTHESIA DELIVERY SYSTEM
K
96
2821
EPIDURAL ANESTHESIA KIT AND COMBINED SPINAL EPIDURAL ANESTHESIA KIT
K
96
1075
MEDCARE REGIONAL ANETHESIA KIT
K
96
0619
MORE-L INJECTOR KIT PLUS
K
95
4706
KENDALL BLUNT TUOHY EPIDURAL NEEDLE
K
95
4953
B-D DURASAFE COMBINED SPINAL EPIDURAL (CSE) TRAY
K
96
0100
SPINAL SPECIALTIES NERVE BLOCK TRAY
K
95
4835
HOLGRATH COMBINED SPINAL EPIDURAL NEEDLE SET
K
95
1870
MORELL INJECTOR
K
95
3790
BD PERISAFE EPIDURAL ANESTHESIA TRAY
K
95
3766
KENDALL SAFETAP SPINAL ANESTHESIA TRAY
K
95
3467
B-D SPINAL ANESTHESIA TRAY SPINAL
K
94
4029
CONTINUOUS EPIDURAL ANESTHESIA TRAY
K
94
3319
GERTIE MARX EPI-SPINAL TRAY
K
94
5484
PIDURAL STEROID SYSTEM
K
95
0929
SENSI-TOUCH EPIDURAL ANESTHESIA TRAY
K
94
1153
EPI-SPINAL ANESTHESIA TRAY
K
94
5671
CONTINUOUS EPIDURAL ANESTHESIA TRAY
K
94
5497
B-D DURASAFE)TM) VARIABLE EXTENSION COMBINED SPINAL EPIDURAL *CSE) NEEDLE SET/KIT
K
93
2614
REGIONAL ANAESTHESIA TRAY
K
94
1343
SPINAL ANESTHESIA TRAY
K
94
1493
KENDALL SAFETRAK COMBINED EPIDURAL/SPINAL KIT
K
93
5245
EPIDURAL ANESTHESIA TRAY
K
93
3721
EPIDURAL ANESTHESIA PROCEDURE TRAY, CUSTOM
K
93
4526
MICRO-SP CUSTOM SPINAL ANESTHESIA TRAY
K
93
1670
CARAPACE EPIDURAL BLOCK & SPINAL MYELOGRAM TRAYS
K
93
3711
E-SP COMBINED EPIDURAL-SPINAL ANESTHESIA TRAY
K
93
2249
DURASAFE B-D COMBINED SPINAL EPIDURAL ANESTHESIA
K
93
0161
ANAGO SPINAL ANESTHESIA TRAY
K
92
4707
VARIOUS ANESTHETIC KITS OR TRAYS
K
92
5014
E-SP COMBINED EPI SPINAL MINISET
K
92
2162
CURITY PLASTIC LOSS OF RESISTANCE SYRINGE
K
92
0615
ANAGO CONTINUOUS EPIDURAL ANESTHESIA TRAY/KIT
K
92
5902
B-D LOSS OF RESISTANCE SYRINGE
K
91
2445
MEGA CONTINUOUS EPIDURAL ANESTHESIA KIT
K
91
2322
MEGA SPINAL ANESTHESIA KIT
K
90
4440
LOCAL PLEXUS BLOCK ANESTHESIA CATHETER KITS
K
90
3761
CURITY SPINAL ANESTHESIA TRAY
K
90
4101
COSPAN CONTINUOUS SPINAL ANESTHESIA TRAY
K
90
3887
CURITY NERVE BLOCK TRAY
K
90
2647
CURITY PEDIATRIC CONTINUOUS CAUDAL ANESTHESIA TRAY
K
90
2312
COSPAN PEDIATRIC CONTINUOUS SPINAL ANESTHESIA TRAY
K
89
6799
PARACERVICAL/PUDENDAL TRAYS
K
89
5955
LOPER CELIAC PLEXUS BLOCK CATHETER KIT
K
89
5476
OPTION EPIDURAL CATHETERS
K
89
6392
MEDTRONIC EPIDURAL CATHETER KIT MODEL 8717
K
89
4725
MEDIZIV EPIDURAL SYSTEMS
K
89
5192
SPINOCAN(R) CONTINUOUS SPINAL TRAY
K
89
2660
HIBERNATION KIT
K
89
3938
CONTINUOUS EPIDURAL ANESTHESIA TRAY
K
89
1281
INTERPLEURAL ANESTHESIA KIT W/POLYURETHANE CATH.
K
89
0732
MEDSURG EPIDURAL TRAY/BULLET TIP/17 GA TUOHY 1002E
K
89
0733
MEDSURG EPIDURAL TRAY/19 GAGE OPEN END TUOHY 1012
K
89
0731
MEDSURG EPIDURAL TRAY/19 GA/BUL TIP/17GA TUO 1002
K
89
0730
MEDSURG EPIDURAL TRAY 19 GAGE/ECON/BULLET TIP 1000
K
88
5278
EPIDURAL ANESTHESIA TRAY
K
88
4552
CONTINUOUS EPIDURAL ANESTHESIA KIT W/POLY CATHETER
K
88
5277
SPINAL ANESTHESIA TRAY
K
88
5238
CURITY CONTINUOUS SPINAL ANESTHESIA TRAY
K
88
3314
PMT 3721-1 EPIDURAL KIT
K
88
2394
MEDTRONIC EPIDURAL CATHETER KIT MODEL 8716
K
88
1429
YANKAUER SUCTION INSTRU./LAYTEX GLOVES/SUCT. CATH.
K
88
0970
AXILLARY BLOCK NEEDLE
K
87
4674
AIK-100 ANESTHESIA INDUCTION KIT/TRAY
K
88
0181
REGANES DISPOSABLE EPIDURAL ANESTHESIA TRAY
K
87
4105
BRACHIAL PLEXUS CATHETER - BP-01200
K
87
3943
CONTINUOUS EPIDURAL ANESTH. KITS W/NYLON CATHETERS
K
87
1066
CURITY CONTINUOUS EPIDURAL ANESTHESIA TRAY
K
86
0833
EPIDURAL ANESTHESIA TRAY
K
85
4518
EPIDURAL ANESTHESIA TRAY
K
85
1134
REGIONAL ANESTHESIA TRAYS
K
85
1479
VYGON BALLOON FOR IDENTIFICATION OF EPIDURAL 193
K
84
4982
VAS-CATH CONTINOUS EPIDURAL ANESTH. CATH/KIT/TRAY
K
84
2095
EPIDURAL TRAYS
K
84
0179
CONTINUOUS EPIDURAL ANESTHES. TRAY
K
84
0287
BRACHIAL PLEXUS ANESTHESIA TRAY
K
83
2778
EPIDURAL SYRINGE
K
82
2691
VYGON EPIDURAL ANAESTHESIA TRAY
K
81
3186
PERFIX SET FOR EPIDURAL ANESTHESIA W/TUO
K
80
2290
REGIONAL INTRAVENOUS ANESTHESIA KIT
K
80
1912
ARROW POSITIVE PLACEMENT CON/EPIDURAL AN
K
80
1724
CURITY PARACERVICAL/PUDENDAL BLOCK ANES
K
78
1469
POSITIVE PLACEMENT ANETHESIA KIT
K
78
2069
TRAY, AUXILLARY BLOCK
K
78
1052
CONTINUOUS EPIDURAL ANESTHESIA TRAY
K
78
0120
ANESTHESIA TRAY, CAUDAL
K
77
0571
TRAY, ANESTHESIA, EPIDURAL, CONTINUOUS
K
77
0461
ANESTHESIA KIT, EPIDURAL BLOCK, CONTINU.
K
77
0356
ANESTHESIA KIT, EPIDURAL, SINGLE SHOT
K
77
0096
EPIDURAL BLOCK PROCEDURE PACK
K
76
1162
BRACHIAL PLEXUS BLOCK ANESTHESIA KIT
K
76
0352
CIRCUIT, INTENSIVE CARE VENTILATOR
K
76
0343
TRAY, CURITY CONTINUOUS EPIDURAL
K
76
0249
TRAY, STERILE DISPOSABLE ARTHROGRAM
CBF
Chamber, Hyperbaric
CBG
Spreader, Cuff
CBH
Device, Fixation, Tracheal Tube
CBI
Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
CBK
Ventilator, Continuous, Facility Use
CBL
Absorbent, Carbon-Dioxide
CBN
Apparatus, Gas-Scavenging
CBO
Attachment, Intermittent Mandatory Ventilation (Imv)
CBP
Valve, Non-Rebreathing
MOD
Accessory To Continuous Ventilator (Respirator)
CCO
Bed, Rocking, Breathing Assist
CCQ
Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
CCT
Applicator (Laryngo-Tracheal), Topical Anesthesia
CCW
Laryngoscope, Rigid
EPE
Brush, Cleaning, Tracheal Tube
FNC
Tent, Pediatric Aerosol
FOG
Hood, Oxygen, Infant
JAY
Support, Breathing Tube
JOH
Tube Tracheostomy And Tube Cuff
KFZ
Humidifier, Non-Direct Patient Interface (Home-Use)
KGB
Mask, Oxygen, Non-Rebreathing
KHA
Mask, Scavenging
LNZ
Changer, Tube, Endotracheal
MIA
Needle, Spinal, Short Term
MNS
Ventilator, Continuous, Non-Life-Supporting
MNT
Ventilator, Continuous, Minimal Ventilatory Support, Facility Use
MRN
Apparatus, Nitric Oxide Delivery
MRO
Apparatus, Nitric Oxide, Backup Delivery
MZT
Device, Heimlich Maneuver Assist
NFB
Conserver, Oxygen
NHJ
Device, Positive Pressure Breathing, Intermittent
NHK
Resuscitator, Manual, Non Self-Inflating
NMA
Tube, Tracheal, Reprocessed
NMC
Mask, Ventilator, Non-Continuous, Reprocessed
NMR
Needle, Spinal, Short Term, Reprocessed
NNH
Needle, Conduction, Anesthesia, Reprocessed
NOU
Continuous, Ventilator, Home Use
NQY
Ventilator, Continuous, Minimal Ventilatory Support, Home Use
NVO
Spacer, Direct Patient Interface
NVP
Holding Chambers, Direct Patient Interface
NXA
Tracheotomy Care Kit
OBN
Humidifier, Respiratory, Mask (Direct Patient Interface)
OFQ
Anesthesia Kit
OFT
Spinal Epidural Anesthesia Kit
OFU
Spinal Anesthesia Kit
OFV
Regional Anesthesia Kit
OGA
Brachial Plexus Anesthesia Kit
OGB
Caudal Anesthesia Kit
OGC
Continuous Brachial Plexus Block Tray
OGD
Custom Anesthesia Tray
OGE
Epidural Anesthesia Kit
OGF
Glossopharyngeal Anesthesia Kit
OGG
Humidifier Nebulizer Kit
OGH
Laryngoscope Kit
OGI
Nasal Endotracheal Tube Holder Kit
OGJ
Nerve Block Tray
OGL
Oxygen Administration Kit
OLF
Medevac Use Oxygen Generator
ONZ
Mechanical Ventilator
OQU
Airway Monitoring System
PHS
Oral Airway Assist
PMB
External Airway
QAV
High Flow/High Velocity Humidified Oxygen Delivery Device
QBY
Positive Airway Pressure System
QCX
Retrograde Intubation Set
OZR
Intraoral Pressure Gradient Device
QFB
Isocapnic Ventilation Device
Subpart G—Miscellaneous
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
AN
/
subpart-f—therapeutic-devices
/
CAZ
/
K111355
View Source
ECHOBRIGHT
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K111355
510(k) Type
Special
Applicant
LIFE-TECH, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/16/2011
Days to Decision
123 days
Submission Type
Statement