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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
BXH
Gauge, Gas Pressure, Cylinder/Pipeline
1
Product Code
BXM
Stimulator, Nerve, Ac-Powered
2
Product Code
BXN
Stimulator, Nerve, Battery-Powered
2
Product Code
BXO
Transducer, Gas Pressure
1
Product Code
BXP
Transducer, Gas Flow
1
Product Code
BXX
Calibrator, Pressure, Gas
1
Product Code
BXY
Flowmeter, Calibration, Gas
1
Product Code
BYM
Tube, Thorpe, Uncompensated
1
Product Code
BYR
Transducer, Gas Pressure, Differential
1
Product Code
BZQ
Monitor, Breathing Frequency
2
Product Code
CAN
Regulator, Pressure, Gas Cylinder
1
Product Code
CAP
Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
2
Product Code
CAX
Flowmeter, Tube, Thorpe, Back-Pressure Compensated
1
Product Code
CBA
Monitor, Air Embolism, Ultrasonic
2
Product Code
CCN
Flowmeter, Nonback-Pressure Compensated, Bourdon Gauge
1
Product Code
ECX
Cylinder, Compressed Gas, And Valve
1
Product Code
FLS
Monitor, Apnea, Facility Use
2
Product Code
JAX
Pneumotachometer
2
Product Code
JEZ
Monitor, Lung Water Measurement
3
Product Code
KLK
Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
2
Product Code
K
00
3943
MICROGAS 7650 TRANSCUTANEOUS MONITOR
2
Cleared 510(K)
K
99
1644
MICROGAS 7650 TRANSCUTANEOUS MONITOR
2
Cleared 510(K)
K
98
0287
SIEMENS SC9000/SC9015 TCP02/C02 MODULE
2
Cleared 510(K)
K
92
4709
SATCARE OXYGEN CONTROLLER/MONITOR W/ PULSE OXIMETE
2
Cleared 510(K)
K
92
4679
OXYCARE(TM) OXYGEN CONTROLLER/MONITOR
2
Cleared 510(K)
K
92
5910
HEWLETT-PACKARD MODEL M1018A TCPO2/TOPCO2 MODULE
2
Cleared 510(K)
K
89
3133
HORIZON 2110/HORIZON 2210 264-XXX-XXX/261-XXX-XXX
2
Cleared 510(K)
K
87
0805
MODEL 840 TRANSCUTAN. OXYGEN/CARBON DIOX. MONITOR
2
Cleared 510(K)
K
86
1861
515A NEO-TRAK NEONATAL MONITOR
2
Cleared 510(K)
K
86
0124
HORIZON 2000 TRANSCUTANEOUS GAS MONITORING
2
Cleared 510(K)
Show All 47 Submissions
KOI
Stimulator, Nerve, Peripheral, Electric
2
Product Code
LKD
Monitor, Carbon-Dioxide, Cutaneous
2
Product Code
LPP
Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia
2
Product Code
MNR
Ventilatory Effort Recorder
2
Product Code
MRP
Analyzer, Nitric Oxide
2
Product Code
MRQ
Analyzer, Nitrogen Dioxide
2
Product Code
NPF
Monitor, Apnea, Home Use
2
Product Code
PRK
Device Indicating An Exhalation Event
2
Product Code
PUG
Analyzer, Nitrogen Dioxide, Exempt
2
Product Code
PXE
Pressure Monitoring (Air/Gas) Kit
1
Product Code
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
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 16 August 2024 at 11:05 pm
AN
/
subpart-c—monitoring-devices
/
KLK
/
K893133
View Source
HORIZON 2110/HORIZON 2210 264-XXX-XXX/261-XXX-XXX
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K893133
510(k) Type
Traditional
Applicant
MENNEN MEDICAL, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/14/1989
Days to Decision
80 days
FDA Browser
by
Innolitics
Anesthesiology
Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
Subpart B—Diagnostic Devices
Subpart C—Cardiovascular Monitoring Devices
Subpart C—Monitoring Devices
BXH
Gauge, Gas Pressure, Cylinder/Pipeline
BXM
Stimulator, Nerve, Ac-Powered
BXN
Stimulator, Nerve, Battery-Powered
BXO
Transducer, Gas Pressure
BXP
Transducer, Gas Flow
BXX
Calibrator, Pressure, Gas
BXY
Flowmeter, Calibration, Gas
BYM
Tube, Thorpe, Uncompensated
BYR
Transducer, Gas Pressure, Differential
BZQ
Monitor, Breathing Frequency
CAN
Regulator, Pressure, Gas Cylinder
CAP
Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
CAX
Flowmeter, Tube, Thorpe, Back-Pressure Compensated
CBA
Monitor, Air Embolism, Ultrasonic
CCN
Flowmeter, Nonback-Pressure Compensated, Bourdon Gauge
ECX
Cylinder, Compressed Gas, And Valve
FLS
Monitor, Apnea, Facility Use
JAX
Pneumotachometer
JEZ
Monitor, Lung Water Measurement
KLK
Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
K
00
3943
MICROGAS 7650 TRANSCUTANEOUS MONITOR
K
99
1644
MICROGAS 7650 TRANSCUTANEOUS MONITOR
K
98
0287
SIEMENS SC9000/SC9015 TCP02/C02 MODULE
K
92
4709
SATCARE OXYGEN CONTROLLER/MONITOR W/ PULSE OXIMETE
K
92
4679
OXYCARE(TM) OXYGEN CONTROLLER/MONITOR
K
92
5910
HEWLETT-PACKARD MODEL M1018A TCPO2/TOPCO2 MODULE
K
89
3133
HORIZON 2110/HORIZON 2210 264-XXX-XXX/261-XXX-XXX
K
87
0805
MODEL 840 TRANSCUTAN. OXYGEN/CARBON DIOX. MONITOR
K
86
1861
515A NEO-TRAK NEONATAL MONITOR
K
86
0124
HORIZON 2000 TRANSCUTANEOUS GAS MONITORING
Show All 47 Submissions
KOI
Stimulator, Nerve, Peripheral, Electric
LKD
Monitor, Carbon-Dioxide, Cutaneous
LPP
Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia
MNR
Ventilatory Effort Recorder
MRP
Analyzer, Nitric Oxide
MRQ
Analyzer, Nitrogen Dioxide
NPF
Monitor, Apnea, Home Use
PRK
Device Indicating An Exhalation Event
PUG
Analyzer, Nitrogen Dioxide, Exempt
PXE
Pressure Monitoring (Air/Gas) Kit
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
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-c—monitoring-devices
/
KLK
/
K893133
View Source
HORIZON 2110/HORIZON 2210 264-XXX-XXX/261-XXX-XXX
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K893133
510(k) Type
Traditional
Applicant
MENNEN MEDICAL, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/14/1989
Days to Decision
80 days