FDA Browser
by
Innolitics
Anesthesiology
Review Panel
Miscellaneous
Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
CFR Sub-Part
Subpart B—Diagnostic Devices
CFR Sub-Part
BSE
Analyzer, Gas, Helium, Gaseous-Phase
2
Product Code
BSI
Algesimeter, Powered
2
Product Code
BTY
Calculator, Predicted Values, Pulmonary Function
2
Product Code
BXA
Analyzer, Gas, Water Vapor, Gaseous-Phase
1
Product Code
BXL
Algesimeter, Manual
1
Product Code
BXQ
Rhinoanemometer (Measurement Of Nasal Decongestion)
2
Product Code
BXR
Meter, Airway Pressure (Inspiratory Force)
2
Product Code
BXW
Calibrator, Volume, Gas
1
Product Code
BZC
Calculator, Pulmonary Function Data
2
Product Code
BZG
Spirometer, Diagnostic
2
Product Code
K
24
1843
TD-7301 Spirometer (TD-7301)
2
Cleared 510(K)
K
23
1416
Air Next (NVD-02)
2
Cleared 510(K)
K
23
0501
Spirobank Oxi
2
Cleared 510(K)
K
23
0178
EasyOne Sky Spirometer
2
Cleared 510(K)
K
22
2525
Alveoair Digital Spirometer
2
Cleared 510(K)
K
22
2443
Air Smart Extra Spirometer
2
Cleared 510(K)
K
21
3754
SpiroHome Personal, SpiroHome Clinic
2
Cleared 510(K)
K
21
3872
ComPAS2
2
Cleared 510(K)
K
21
2938
Vitalograph Model 6000 Alpha
2
Cleared 510(K)
K
20
1493
Spirometer
2
Cleared 510(K)
K
20
2837
GoSpiro
2
Cleared 510(K)
K
20
1562
Spirotrac
2
Cleared 510(K)
K
20
1002
Safey Pocket Spirometer
2
Cleared 510(K)
K
20
0550
Vitalograph Model 2120 In2itive eDiary
2
Cleared 510(K)
K
18
3089
Air Next
2
Cleared 510(K)
K
18
3479
Asthma Monitor AM3
2
Cleared 510(K)
K
19
1013
Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry option
2
Cleared 510(K)
K
19
0568
ComPAS2 (Computerized Pulmonary Analysis System)
2
Cleared 510(K)
K
18
0011
Pulmonx Chartis Tablet Console
2
Cleared 510(K)
K
16
3249
GoSpiro
2
Cleared 510(K)
K
16
1536
EasyOne Air Spirometer
2
Cleared 510(K)
K
16
1676
Q13 SPIROLYSER®
2
Cleared 510(K)
K
16
0116
SpiroScout
2
Cleared 510(K)
K
16
0253
Vitalograph Model 6300 micro
2
Cleared 510(K)
K
15
0515
IQSense Flow Sensor Mouthpiece
2
Cleared 510(K)
K
14
2642
Vitalograph Model 6600 Compact
2
Cleared 510(K)
K
14
2812
Vitalograph Model 6800 Pneumotrac
2
Cleared 510(K)
K
12
0577
MEDIKRO SPIROSTAR, M929 Medikro Spirostar USB and M921 Medikro SpiroStar DX
2
Cleared 510(K)
K
15
0137
SpiroThor
2
Cleared 510(K)
K
14
1793
PULMONE MINIBOXPFT 2.0
2
Cleared 510(K)
K
14
1936
MICROBLAB, MICROLOOP
2
Cleared 510(K)
K
14
2303
NeumoFilt Ergo/Neumo Filt BiteOn
2
Cleared 510(K)
K
14
1546
VITALOGRAPH MODEL 7000 SPIROTRAC
2
Cleared 510(K)
K
13
3428
MEDIKRO NANO, MEDIKRO PRIMO AND MEDIKRO PRO
2
Cleared 510(K)
K
13
3722
ASTHMA MONITOR AM3
2
Cleared 510(K)
K
13
0322
SPM-300
2
Cleared 510(K)
K
13
0784
SPIROTEL
2
Cleared 510(K)
K
12
3896
CCS-200 SPIROMETER
2
Cleared 510(K)
K
12
2384
MINISPIR
2
Cleared 510(K)
K
12
0880
ORBIT
2
Cleared 510(K)
K
11
3096
MICRO I
2
Cleared 510(K)
K
10
3530
SPIRODOC
2
Cleared 510(K)
K
11
1764
CHARTIS CONSOLE
2
Cleared 510(K)
K
10
3575
SPIRO PD
2
Cleared 510(K)
K
11
1587
ALERKAN SPIROMETRY FILTER
2
Cleared 510(K)
K
10
0928
MICRO DIARY SPIROMETER
2
Cleared 510(K)
K
10
1873
MASTERSCREEN IOS
2
Cleared 510(K)
K
10
0687
VITALOGRAPH HAND HELD SPIROMETER, MODEL 2120
2
Cleared 510(K)
K
09
2813
ASTRASONIC SPIROMETER, MODEL 29-8000
2
Cleared 510(K)
K
09
3174
SPIROPALM
2
Cleared 510(K)
K
09
2890
ASTHMA MONITOR AM3
2
Cleared 510(K)
K
09
0646
CARDIOTECH SPIROMETRY SYSTEM, MODEL GT-105
2
Cleared 510(K)
K
08
3199
CHARTIS CONSOLE
2
Cleared 510(K)
K
09
0034
EASY ON-PC SPIROMETER
2
Cleared 510(K)
K
09
0486
ASTHMA MONITOR MODEL, AM1
2
Cleared 510(K)
K
08
2478
WELCH ALLYN CARDIOPERFECT WORKSTATION SOFTWARE (CPWS) V 1.62
2
Cleared 510(K)
K
08
3233
THE PFT FILTER
2
Cleared 510(K)
K
08
3879
INNOCOR ERGOSPIROMETRY SYSTEM (INN00010), THE BASIC INNOCOR INCLUDING BREATH-BY-BREATH SYSTEM (INN00400), NIBP(INN00500)
2
Cleared 510(K)
K
08
0921
SPIRO-MASTER PC-10 SPIROMETRY SYSTEM
2
Cleared 510(K)
K
08
2766
MODIFICATION TO MINISPIR, SPIROLAB III
2
Cleared 510(K)
K
07
3155
VITALOGRAPH MODEL 4000 (ASMA-1 AND COPD-6)
2
Cleared 510(K)
K
07
2722
MEDDORNA WIRELESS PRN SPIROMETER 100
2
Cleared 510(K)
K
07
2979
SPIROBANK G
2
Cleared 510(K)
K
06
1571
ASTRA 300
2
Cleared 510(K)
K
06
2913
ASTRAGUARD PULMONARY FUNCTION FILTER
2
Cleared 510(K)
K
06
1283
PULMOLIFE
2
Cleared 510(K)
K
06
1875
MINISPIR; SPIROLAB III
2
Cleared 510(K)
K
06
1712
SPIROBANK II
2
Cleared 510(K)
K
05
2140
SPIROLAB, SPIROLAB II
2
Cleared 510(K)
K
05
2176
FLOWHANDY ZAN100 USB
2
Cleared 510(K)
K
05
1572
KOKO LEGEND
2
Cleared 510(K)
K
05
2158
WELCH ALLYN CARDIOPERFECT WORKSTATION VERSION 1.5.0 SOFTWARE
2
Cleared 510(K)
K
05
1712
MODEL 2800 PFT FILTER
2
Cleared 510(K)
K
04
2758
POLYTECH PULMONARY FUNCTION FILTER
2
Cleared 510(K)
K
04
3528
SPIROTEL
2
Cleared 510(K)
K
05
0424
ERGOFILTER SPI ACCESSORY TO SPIROLYSER SPL-50
2
Cleared 510(K)
K
04
2595
SPIRO'AIR
2
Cleared 510(K)
K
04
2058
ONEFLOW FVC, ONEFLOW FVC (KIT), ONEFLOW FVC SCREEN
2
Cleared 510(K)
K
03
3518
LOTUS PULMONARY FUNCTION FILTER, MODELS CPF 101, CPF 102, CPF 103
2
Cleared 510(K)
K
03
3939
FLOSENSE II, MODEL 29-8040
2
Cleared 510(K)
K
03
1643
SPIROTEL, MODEL 29-1020
2
Cleared 510(K)
K
03
1102
MICROLAB SPIROMETER
2
Cleared 510(K)
K
03
0917
GEM; HAWK; EAGLE; MODELS 004110, 0044120, 004130
2
Cleared 510(K)
K
02
0102
IQTEQ SPIROMETER
2
Cleared 510(K)
K
03
0464
GEM, MODEL 004110
2
Cleared 510(K)
K
02
3225
PURITAN BENNETT DATAFLOW DATA MANAGEMENT SOFTWARE
2
Cleared 510(K)
K
02
1200
COMPAS
2
Cleared 510(K)
K
02
2276
KOKOMATE
2
Cleared 510(K)
K
02
2103
PURITAN-BENNETT 700 RENAISSANCE II SPIROMETRY SYSTEM
2
Cleared 510(K)
K
02
0280
PULMOLAB EX671 EXERCISE TESTING SYSTEM
2
Cleared 510(K)
K
02
0004
CLINDATALINK VERSION 1.0 FOR SPIROMETRY
2
Cleared 510(K)
K
01
3123
EMS PULMONARY FUNCTION TESTING FILTER
2
Cleared 510(K)
K
01
0761
SPL-50 SPIROLYSER
2
Cleared 510(K)
K
01
3812
SPIROLAB II, MODEL 29
2
Cleared 510(K)
K
01
3752
COMPAS AS (COMPUTERIZED PULMONARY ANALYSIS SYSTEM)
2
Cleared 510(K)
K
01
1470
SDI SB OFFICE, MODEL 29-
2
Cleared 510(K)
K
00
1528
PC FLOW +
2
Cleared 510(K)
K
00
1278
SENSAIRE DIAGNOSTIC SPIROMETER
2
Cleared 510(K)
K
00
2499
BRENTWOOD IQMARK DIGITAL SPIROMETER (INCLUDES DISPOSABLE PNEUMOTACH MOUTHPIECES AND 3-LITER CALIBRATION SYRINGE
2
Cleared 510(K)
K
00
0599
VITALOGRAPH BASE STATION
2
Cleared 510(K)
K
99
3921
NDD MEDICAL TECHNOLOGIES EASYONE SPIROMETER: FRONTLINE MODEL 2000 AND DIAGNOSTIC MODEL 2001
2
Cleared 510(K)
K
99
2823
SPIROVIT SP-2, PNEUMOCHECK II
2
Cleared 510(K)
K
99
2743
COLLINS CPL
2
Cleared 510(K)
K
98
4031
SPIROVIT, MODEL SP-250
2
Cleared 510(K)
K
98
3909
MIR SPIROBANK SPIROMETER
2
Cleared 510(K)
K
97
1336
CAIRD TECHNOLOGY SPIROMETER
2
Cleared 510(K)
K
98
2956
FLOWMATE II PLUS, MODEL #4000
2
Cleared 510(K)
K
97
3138
SPIROCARD
2
Cleared 510(K)
K
98
0876
ASTHMA MONITOR AM2
2
Cleared 510(K)
K
97
3456
SPIROBANK PORTABLE PC BASED SPIROMETER
2
Cleared 510(K)
K
98
0441
SPIROMETER MODEL NPB-500
2
Cleared 510(K)
K
96
5042
MICRODL DIARYCARD SPIROMETER
2
Cleared 510(K)
K
96
3131
GRASEBY ANDERSEN'S, INTEGRITY S700
2
Cleared 510(K)
K
96
3035
MICRO SPIROMETER
2
Cleared 510(K)
K
96
0078
ASTHMA MONITOR
2
Cleared 510(K)
K
95
3948
SPIROVISION SV-III PC BASED SPIROMETER KIT MICRO
2
Cleared 510(K)
K
95
4759
FLOWMATE LTE
2
Cleared 510(K)
K
95
1718
HM-SPIRO
2
Cleared 510(K)
K
95
4140
MASTERSCREEN IOS
2
Cleared 510(K)
K
95
0223
DISCOVERY GRAPHIC PORTABLE SPIROMETER
2
Cleared 510(K)
K
95
1227
DX1
2
Cleared 510(K)
K
94
6075
VITALOGRAPH MODEL 2120
2
Cleared 510(K)
K
94
6322
POLYGRAM SOFTWARE
2
Cleared 510(K)
K
95
1367
PORTA-SCREEN SPIROMETER
2
Cleared 510(K)
K
94
3546
FUKUDA SANGYO MODEL SPIROANALYZER ST-180
2
Cleared 510(K)
K
94
4762
PURITAN-BENNETT RENAISSANCE SPIROMETRY SYSTEMWITH THE OPTIONALRENAISSANCE DB DATA MANAGEMENTSOFTWARE
2
Cleared 510(K)
K
94
4175
ADAM SHELL THERMOCOUPLE ASSEMBLY
2
Cleared 510(K)
K
94
2779
DISPOSABLE BACTERIOLOGICAL FILTER
2
Cleared 510(K)
K
93
2936
L.A.P. II SPRIOMETRY SYSTEM
2
Cleared 510(K)
K
92
5459
GS-MODULAR (GOLD STANDARD - MODULAR)
2
Cleared 510(K)
K
92
3988
SENSORMEDICS MODEL 2200 PULMONARY FUNCTION LABS
2
Cleared 510(K)
K
92
5085
ESCORT SPIROMETER
2
Cleared 510(K)
K
92
3989
SENSORMEDICS MODEL 6200 AUTOBOX DL
2
Cleared 510(K)
K
92
4413
FLOWSCAN
2
Cleared 510(K)
K
92
1513
SPIROLITE MODEL MSC-201 SPIROMETER
2
Cleared 510(K)
K
92
2428
FUKUDA DENSHI MODEL SPIROSIFT SP-5000
2
Cleared 510(K)
K
92
0877
THE KEYSTONE SYSTEM
2
Cleared 510(K)
K
92
0111
SENSORMEDICS MODEL 2130 SPIEOMETRY SYSTEM
2
Cleared 510(K)
K
91
5451
MULTISPIRO-SX
2
Cleared 510(K)
K
91
4272
KOKO SPIROMETER
2
Cleared 510(K)
K
91
3396
CANNULA STYLE THERMOCOUPLES
2
Cleared 510(K)
K
91
3395
EZ-1 SYSTEM RESPIRATORY EFFORT SENSORS
2
Cleared 510(K)
K
91
4205
PFF-1
2
Cleared 510(K)
K
92
0246
SENSORMEDICS MODEL 922 SPIROMETER
2
Cleared 510(K)
K
91
4219
AIRWAY THERMISTOR
2
Cleared 510(K)
K
91
4085
HMS-5000
2
Cleared 510(K)
K
91
2412
VITALOGRAPH SPIROTRAC III
2
Cleared 510(K)
K
90
4625
SYNECTICS LIBERTY SYSTEM, PC POLYGRAF AND POLYGRAM
2
Cleared 510(K)
K
91
0950
HMS-4000 MULTICHANNEL PHYSIO MONIT SYST, MODIFIED
2
Cleared 510(K)
K
91
2234
SOMNIPROBE(R) MODEL NUMBER 10093, MODIFICATION
2
Cleared 510(K)
K
90
4200
SPIROSIFT 500A
2
Cleared 510(K)
K
91
0452
RESPI-PAK RT-PAK
2
Cleared 510(K)
K
90
4118
SOMNIPROBE II NASAL AND BUCCAL AIRFLOW MON. SYST.
2
Cleared 510(K)
K
90
4117
SOMNIGAUGE THORACIC/ABDOMINAL EXPANSION MON. SYST.
2
Cleared 510(K)
K
90
4947
PM2002 CC, ARISTOCRAT AND ARISTOCRAT DELUXE
2
Cleared 510(K)
K
90
0331
TUBA TM (TRANSIT-TIME ULTRASONIC BREATH ANALYZER)
2
Cleared 510(K)
K
90
1308
SPIRO ANALYZER MODEL ST 250
2
Cleared 510(K)
K
90
0391
FUKUDA DENSHI MODEL SPIROSIFT 3000
2
Cleared 510(K)
K
90
1057
SPIROMETRICS MODEL 2600 MIRO SPIROMETER
2
Cleared 510(K)
K
90
0673
SERIAL FLOW
2
Cleared 510(K)
K
89
6300
LDW SPIROMETRY SYSTEM
2
Cleared 510(K)
K
89
6924
SPIROSCAN 4000
2
Cleared 510(K)
K
89
5414
MULTIMED (TM) PULMONARY FUNCTION TESTING SYSTEM
2
Cleared 510(K)
K
89
5953
WRIGHT VENTILOMETER VM-1
2
Cleared 510(K)
K
89
7094
MODIFIED SPIROSCAN 1000
2
Cleared 510(K)
K
89
6120
SCHILLER MODEL SP-100 SPIROVIT(TM)
2
Cleared 510(K)
K
89
6121
SCHILLER MODEL SP-200 SPIROVIT(TM)
2
Cleared 510(K)
K
89
4556
SPIROTEQ
2
Cleared 510(K)
K
89
5375
MULTISPIRO
2
Cleared 510(K)
K
89
5253
PNEUMOCHECK W/PRINTER/CHARGER AND ACCESSORIES
2
Cleared 510(K)
K
89
4997
PRESTO DIAGNOSTIC SPIROMETER
2
Cleared 510(K)
K
89
4680
RS232 FLOW SENSOR AND SOFTWARE PACKAGE
2
Cleared 510(K)
K
89
1672
PUL-TRON 100K PROFESSIONAL SPIROMETER
2
Cleared 510(K)
K
89
0522
PURITAN BENNETT PB900A DIAGNOSTIC SPIROMETER
2
Cleared 510(K)
K
88
1402
629V SPIROMETER, PULMONARY FUNCTION ANALYZER
2
Cleared 510(K)
K
87
3562
VITALOGRAPH-ALPHA
2
Cleared 510(K)
K
87
3817
SPIRO ANALYZER ST-300
2
Cleared 510(K)
K
86
3134
MULTISPIRO SA/100
2
Cleared 510(K)
K
86
3656
SALTER VOLUCHEK 6600
2
Cleared 510(K)
K
86
2023
SPIROMATE AS-600
2
Cleared 510(K)
K
86
1227
COLLINS PNEUMOTACH PFT SYSTEM
2
Cleared 510(K)
K
86
0522
SPIROMETER, MODEL TS-1000, PART NO. SLZ7504
2
Cleared 510(K)
K
85
3409
SCREENMATE
2
Cleared 510(K)
K
85
4403
MODEL 2120 SPIROSCREEN
2
Cleared 510(K)
K
85
4526
VITALOGRAPH COMPACT
2
Cleared 510(K)
K
85
4062
PALL PULMONARY FUNCTION FILTER
2
Cleared 510(K)
K
85
2092
PB900 PB910 DIAGNOSTIC SPIROMETER
2
Cleared 510(K)
K
85
2677
MTS4400 METABOLIC & RESPIRATORY TESTING SYSTEM
2
Cleared 510(K)
K
85
2307
PULMONARY TEST SYSTEM FUDAC-30
2
Cleared 510(K)
K
85
2337
PNEUMOSCOPE
2
Cleared 510(K)
K
85
1135
SPIRO SCAN
2
Cleared 510(K)
K
85
2308
ST-460 SPIRO ANALYZER SPIROMETER
2
Cleared 510(K)
K
85
1620
SPIROMED 2
2
Cleared 510(K)
K
85
1277
MICROSPIRO-SDS
2
Cleared 510(K)
K
84
3841
ERGO-OXYSCREEN
2
Cleared 510(K)
K
84
4333
SPIROMETRICS 2451 & SMI I
2
Cleared 510(K)
K
84
4226
B-1000
2
Cleared 510(K)
K
84
3996
TURBOAIRE CHALLANGER ENVIRONMENTAL AIR CONTROLLER
2
Cleared 510(K)
K
84
3984
PM-80 PULMOTESTER
2
Cleared 510(K)
K
84
2536
CDX80
2
Cleared 510(K)
K
84
2372
SPIROMATE AS-500
2
Cleared 510(K)
K
84
0972
SPIROTECH ST-550
2
Cleared 510(K)
K
84
2041
PULMONARY FUNCTION SYSTEM
2
Cleared 510(K)
K
84
0929
FRC 85 SERIES SPIROMETER
2
Cleared 510(K)
K
84
0908
CHESTAC-25F SPIROMETER
2
Cleared 510(K)
K
83
2401
RESPIROMETER
2
Cleared 510(K)
K
83
1803
PULMOMETER
2
Cleared 510(K)
K
84
0741
PULMONARY FUNCTION TESTING STS
2
Cleared 510(K)
K
83
4475
RESPIRODYNE PULMONARY FUNCTION TEST
2
Cleared 510(K)
K
83
2432
SPIRO ANALYZER ST-100 AUTOMATIC SPIRO
2
Cleared 510(K)
K
83
2431
FUKUNDA SANGYA UNITS PULMOTESTER PM60
2
Cleared 510(K)
K
83
2430
FUKUNDA SANGYO UNITS ELECTRONIC SPIRO
2
Cleared 510(K)
K
83
2433
AUTOMATIC SPIROMETER ST-200
2
Cleared 510(K)
K
83
2185
OHIO MODEL 922 SPIROMETER
2
Cleared 510(K)
K
83
1497
SPIROMETRICS BREON 2400 & SMI 2400
2
Cleared 510(K)
K
82
3770
SPIROTECH ST-5500
2
Cleared 510(K)
K
82
2861
LIFELINE 4800-C DIGITAL SPIROMETER
2
Cleared 510(K)
K
82
0599
AUTOSPIROMETER HI-498
2
Cleared 510(K)
K
82
0032
VIT-O-METER
2
Cleared 510(K)
K
82
0036
CXD 400
2
Cleared 510(K)
K
81
2039
SPIROMETER 210/211
2
Cleared 510(K)
K
81
0437
BREATH METER
2
Cleared 510(K)
K
79
1422
MINISPIROMETER SP-1
2
Cleared 510(K)
K
79
1177
DISPIRO
2
Cleared 510(K)
K
78
0894
AIRFLOMETER
2
Cleared 510(K)
K
77
0928
PART NO. 66-00121
2
Cleared 510(K)
K
77
0927
PART NO. 66-00311
2
Cleared 510(K)
BZH
Meter, Peak Flow, Spirometry
2
Product Code
BZK
Spirometer, Monitoring (W/Wo Alarm)
2
Product Code
BZL
Computer, Oxygen-Uptake
2
Product Code
BZM
Calculator, Pulmonary Function Interpretor (Diagnostic)
2
Product Code
BZS
Stethoscope Head
1
Product Code
BZT
Stethoscope, Esophageal, With Electrical Conductors
2
Product Code
BZW
Stethoscope, Esophageal
1
Product Code
CBQ
Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)
2
Product Code
CBR
Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)
2
Product Code
CBS
Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)
2
Product Code
CBT
Arterial Blood Sampling Kit
1
Product Code
CBZ
Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling
2
Product Code
CCC
Analyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling
2
Product Code
CCE
Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling
2
Product Code
CCI
Analyzer, Gas, Nitrogen, Gaseous-Phase
2
Product Code
CCJ
Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase
2
Product Code
CCK
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
2
Product Code
CCL
Analyzer, Gas, Oxygen, Gaseous-Phase
2
Product Code
CCM
Plethysmograph, Pressure
2
Product Code
JED
Analyzer, Oxyhemoglobin Concentration, Blood-Phase, Indwelling
3
Product Code
JEF
Analyzer, Gas, Neon, Gaseous-Phase
2
Product Code
JEG
Analyzer, Gas, Argon, Gaseous-Phase
2
Product Code
JEH
Plethysmograph, Volume
2
Product Code
JFE
Valve, Switching (Ploss)
1
Product Code
KGK
Gas, Collecting Vessel
1
Product Code
NHO
Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)
2
Product Code
NHP
Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)
2
Product Code
NHQ
Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)
2
Product Code
OFZ
Blood Specimen Collection Kit (Excludes Hiv Testing)
1
Product Code
PNV
Impedance Measuring Device Utilizing Oscillation Techniques
2
Product Code
OGK
Orotracheal Intubation Guide Kit
2
Product Code
PHZ
Abnormal Breath Sound Device
2
Product Code
QEB
Ventilatory Electrical Impedance Tomograph
2
Product Code
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
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-b—diagnostic-devices
/
BZG
/
K894556
View Source
SPIROTEQ
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K894556
510(k) Type
Traditional
Applicant
SYSTEM ANALYSIS CORP.
Country
France
FDA Decision
Substantially Equivalent
Decision Date
1/9/1990
Days to Decision
173 days
FDA Browser
by
Innolitics
Anesthesiology
Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
Subpart B—Diagnostic Devices
BSE
Analyzer, Gas, Helium, Gaseous-Phase
BSI
Algesimeter, Powered
BTY
Calculator, Predicted Values, Pulmonary Function
BXA
Analyzer, Gas, Water Vapor, Gaseous-Phase
BXL
Algesimeter, Manual
BXQ
Rhinoanemometer (Measurement Of Nasal Decongestion)
BXR
Meter, Airway Pressure (Inspiratory Force)
BXW
Calibrator, Volume, Gas
BZC
Calculator, Pulmonary Function Data
BZG
Spirometer, Diagnostic
K
24
1843
TD-7301 Spirometer (TD-7301)
K
23
1416
Air Next (NVD-02)
K
23
0501
Spirobank Oxi
K
23
0178
EasyOne Sky Spirometer
K
22
2525
Alveoair Digital Spirometer
K
22
2443
Air Smart Extra Spirometer
K
21
3754
SpiroHome Personal, SpiroHome Clinic
K
21
3872
ComPAS2
K
21
2938
Vitalograph Model 6000 Alpha
K
20
1493
Spirometer
K
20
2837
GoSpiro
K
20
1562
Spirotrac
K
20
1002
Safey Pocket Spirometer
K
20
0550
Vitalograph Model 2120 In2itive eDiary
K
18
3089
Air Next
K
18
3479
Asthma Monitor AM3
K
19
1013
Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry option
K
19
0568
ComPAS2 (Computerized Pulmonary Analysis System)
K
18
0011
Pulmonx Chartis Tablet Console
K
16
3249
GoSpiro
K
16
1536
EasyOne Air Spirometer
K
16
1676
Q13 SPIROLYSER®
K
16
0116
SpiroScout
K
16
0253
Vitalograph Model 6300 micro
K
15
0515
IQSense Flow Sensor Mouthpiece
K
14
2642
Vitalograph Model 6600 Compact
K
14
2812
Vitalograph Model 6800 Pneumotrac
K
12
0577
MEDIKRO SPIROSTAR, M929 Medikro Spirostar USB and M921 Medikro SpiroStar DX
K
15
0137
SpiroThor
K
14
1793
PULMONE MINIBOXPFT 2.0
K
14
1936
MICROBLAB, MICROLOOP
K
14
2303
NeumoFilt Ergo/Neumo Filt BiteOn
K
14
1546
VITALOGRAPH MODEL 7000 SPIROTRAC
K
13
3428
MEDIKRO NANO, MEDIKRO PRIMO AND MEDIKRO PRO
K
13
3722
ASTHMA MONITOR AM3
K
13
0322
SPM-300
K
13
0784
SPIROTEL
K
12
3896
CCS-200 SPIROMETER
K
12
2384
MINISPIR
K
12
0880
ORBIT
K
11
3096
MICRO I
K
10
3530
SPIRODOC
K
11
1764
CHARTIS CONSOLE
K
10
3575
SPIRO PD
K
11
1587
ALERKAN SPIROMETRY FILTER
K
10
0928
MICRO DIARY SPIROMETER
K
10
1873
MASTERSCREEN IOS
K
10
0687
VITALOGRAPH HAND HELD SPIROMETER, MODEL 2120
K
09
2813
ASTRASONIC SPIROMETER, MODEL 29-8000
K
09
3174
SPIROPALM
K
09
2890
ASTHMA MONITOR AM3
K
09
0646
CARDIOTECH SPIROMETRY SYSTEM, MODEL GT-105
K
08
3199
CHARTIS CONSOLE
K
09
0034
EASY ON-PC SPIROMETER
K
09
0486
ASTHMA MONITOR MODEL, AM1
K
08
2478
WELCH ALLYN CARDIOPERFECT WORKSTATION SOFTWARE (CPWS) V 1.62
K
08
3233
THE PFT FILTER
K
08
3879
INNOCOR ERGOSPIROMETRY SYSTEM (INN00010), THE BASIC INNOCOR INCLUDING BREATH-BY-BREATH SYSTEM (INN00400), NIBP(INN00500)
K
08
0921
SPIRO-MASTER PC-10 SPIROMETRY SYSTEM
K
08
2766
MODIFICATION TO MINISPIR, SPIROLAB III
K
07
3155
VITALOGRAPH MODEL 4000 (ASMA-1 AND COPD-6)
K
07
2722
MEDDORNA WIRELESS PRN SPIROMETER 100
K
07
2979
SPIROBANK G
K
06
1571
ASTRA 300
K
06
2913
ASTRAGUARD PULMONARY FUNCTION FILTER
K
06
1283
PULMOLIFE
K
06
1875
MINISPIR; SPIROLAB III
K
06
1712
SPIROBANK II
K
05
2140
SPIROLAB, SPIROLAB II
K
05
2176
FLOWHANDY ZAN100 USB
K
05
1572
KOKO LEGEND
K
05
2158
WELCH ALLYN CARDIOPERFECT WORKSTATION VERSION 1.5.0 SOFTWARE
K
05
1712
MODEL 2800 PFT FILTER
K
04
2758
POLYTECH PULMONARY FUNCTION FILTER
K
04
3528
SPIROTEL
K
05
0424
ERGOFILTER SPI ACCESSORY TO SPIROLYSER SPL-50
K
04
2595
SPIRO'AIR
K
04
2058
ONEFLOW FVC, ONEFLOW FVC (KIT), ONEFLOW FVC SCREEN
K
03
3518
LOTUS PULMONARY FUNCTION FILTER, MODELS CPF 101, CPF 102, CPF 103
K
03
3939
FLOSENSE II, MODEL 29-8040
K
03
1643
SPIROTEL, MODEL 29-1020
K
03
1102
MICROLAB SPIROMETER
K
03
0917
GEM; HAWK; EAGLE; MODELS 004110, 0044120, 004130
K
02
0102
IQTEQ SPIROMETER
K
03
0464
GEM, MODEL 004110
K
02
3225
PURITAN BENNETT DATAFLOW DATA MANAGEMENT SOFTWARE
K
02
1200
COMPAS
K
02
2276
KOKOMATE
K
02
2103
PURITAN-BENNETT 700 RENAISSANCE II SPIROMETRY SYSTEM
K
02
0280
PULMOLAB EX671 EXERCISE TESTING SYSTEM
K
02
0004
CLINDATALINK VERSION 1.0 FOR SPIROMETRY
K
01
3123
EMS PULMONARY FUNCTION TESTING FILTER
K
01
0761
SPL-50 SPIROLYSER
K
01
3812
SPIROLAB II, MODEL 29
K
01
3752
COMPAS AS (COMPUTERIZED PULMONARY ANALYSIS SYSTEM)
K
01
1470
SDI SB OFFICE, MODEL 29-
K
00
1528
PC FLOW +
K
00
1278
SENSAIRE DIAGNOSTIC SPIROMETER
K
00
2499
BRENTWOOD IQMARK DIGITAL SPIROMETER (INCLUDES DISPOSABLE PNEUMOTACH MOUTHPIECES AND 3-LITER CALIBRATION SYRINGE
K
00
0599
VITALOGRAPH BASE STATION
K
99
3921
NDD MEDICAL TECHNOLOGIES EASYONE SPIROMETER: FRONTLINE MODEL 2000 AND DIAGNOSTIC MODEL 2001
K
99
2823
SPIROVIT SP-2, PNEUMOCHECK II
K
99
2743
COLLINS CPL
K
98
4031
SPIROVIT, MODEL SP-250
K
98
3909
MIR SPIROBANK SPIROMETER
K
97
1336
CAIRD TECHNOLOGY SPIROMETER
K
98
2956
FLOWMATE II PLUS, MODEL #4000
K
97
3138
SPIROCARD
K
98
0876
ASTHMA MONITOR AM2
K
97
3456
SPIROBANK PORTABLE PC BASED SPIROMETER
K
98
0441
SPIROMETER MODEL NPB-500
K
96
5042
MICRODL DIARYCARD SPIROMETER
K
96
3131
GRASEBY ANDERSEN'S, INTEGRITY S700
K
96
3035
MICRO SPIROMETER
K
96
0078
ASTHMA MONITOR
K
95
3948
SPIROVISION SV-III PC BASED SPIROMETER KIT MICRO
K
95
4759
FLOWMATE LTE
K
95
1718
HM-SPIRO
K
95
4140
MASTERSCREEN IOS
K
95
0223
DISCOVERY GRAPHIC PORTABLE SPIROMETER
K
95
1227
DX1
K
94
6075
VITALOGRAPH MODEL 2120
K
94
6322
POLYGRAM SOFTWARE
K
95
1367
PORTA-SCREEN SPIROMETER
K
94
3546
FUKUDA SANGYO MODEL SPIROANALYZER ST-180
K
94
4762
PURITAN-BENNETT RENAISSANCE SPIROMETRY SYSTEMWITH THE OPTIONALRENAISSANCE DB DATA MANAGEMENTSOFTWARE
K
94
4175
ADAM SHELL THERMOCOUPLE ASSEMBLY
K
94
2779
DISPOSABLE BACTERIOLOGICAL FILTER
K
93
2936
L.A.P. II SPRIOMETRY SYSTEM
K
92
5459
GS-MODULAR (GOLD STANDARD - MODULAR)
K
92
3988
SENSORMEDICS MODEL 2200 PULMONARY FUNCTION LABS
K
92
5085
ESCORT SPIROMETER
K
92
3989
SENSORMEDICS MODEL 6200 AUTOBOX DL
K
92
4413
FLOWSCAN
K
92
1513
SPIROLITE MODEL MSC-201 SPIROMETER
K
92
2428
FUKUDA DENSHI MODEL SPIROSIFT SP-5000
K
92
0877
THE KEYSTONE SYSTEM
K
92
0111
SENSORMEDICS MODEL 2130 SPIEOMETRY SYSTEM
K
91
5451
MULTISPIRO-SX
K
91
4272
KOKO SPIROMETER
K
91
3396
CANNULA STYLE THERMOCOUPLES
K
91
3395
EZ-1 SYSTEM RESPIRATORY EFFORT SENSORS
K
91
4205
PFF-1
K
92
0246
SENSORMEDICS MODEL 922 SPIROMETER
K
91
4219
AIRWAY THERMISTOR
K
91
4085
HMS-5000
K
91
2412
VITALOGRAPH SPIROTRAC III
K
90
4625
SYNECTICS LIBERTY SYSTEM, PC POLYGRAF AND POLYGRAM
K
91
0950
HMS-4000 MULTICHANNEL PHYSIO MONIT SYST, MODIFIED
K
91
2234
SOMNIPROBE(R) MODEL NUMBER 10093, MODIFICATION
K
90
4200
SPIROSIFT 500A
K
91
0452
RESPI-PAK RT-PAK
K
90
4118
SOMNIPROBE II NASAL AND BUCCAL AIRFLOW MON. SYST.
K
90
4117
SOMNIGAUGE THORACIC/ABDOMINAL EXPANSION MON. SYST.
K
90
4947
PM2002 CC, ARISTOCRAT AND ARISTOCRAT DELUXE
K
90
0331
TUBA TM (TRANSIT-TIME ULTRASONIC BREATH ANALYZER)
K
90
1308
SPIRO ANALYZER MODEL ST 250
K
90
0391
FUKUDA DENSHI MODEL SPIROSIFT 3000
K
90
1057
SPIROMETRICS MODEL 2600 MIRO SPIROMETER
K
90
0673
SERIAL FLOW
K
89
6300
LDW SPIROMETRY SYSTEM
K
89
6924
SPIROSCAN 4000
K
89
5414
MULTIMED (TM) PULMONARY FUNCTION TESTING SYSTEM
K
89
5953
WRIGHT VENTILOMETER VM-1
K
89
7094
MODIFIED SPIROSCAN 1000
K
89
6120
SCHILLER MODEL SP-100 SPIROVIT(TM)
K
89
6121
SCHILLER MODEL SP-200 SPIROVIT(TM)
K
89
4556
SPIROTEQ
K
89
5375
MULTISPIRO
K
89
5253
PNEUMOCHECK W/PRINTER/CHARGER AND ACCESSORIES
K
89
4997
PRESTO DIAGNOSTIC SPIROMETER
K
89
4680
RS232 FLOW SENSOR AND SOFTWARE PACKAGE
K
89
1672
PUL-TRON 100K PROFESSIONAL SPIROMETER
K
89
0522
PURITAN BENNETT PB900A DIAGNOSTIC SPIROMETER
K
88
1402
629V SPIROMETER, PULMONARY FUNCTION ANALYZER
K
87
3562
VITALOGRAPH-ALPHA
K
87
3817
SPIRO ANALYZER ST-300
K
86
3134
MULTISPIRO SA/100
K
86
3656
SALTER VOLUCHEK 6600
K
86
2023
SPIROMATE AS-600
K
86
1227
COLLINS PNEUMOTACH PFT SYSTEM
K
86
0522
SPIROMETER, MODEL TS-1000, PART NO. SLZ7504
K
85
3409
SCREENMATE
K
85
4403
MODEL 2120 SPIROSCREEN
K
85
4526
VITALOGRAPH COMPACT
K
85
4062
PALL PULMONARY FUNCTION FILTER
K
85
2092
PB900 PB910 DIAGNOSTIC SPIROMETER
K
85
2677
MTS4400 METABOLIC & RESPIRATORY TESTING SYSTEM
K
85
2307
PULMONARY TEST SYSTEM FUDAC-30
K
85
2337
PNEUMOSCOPE
K
85
1135
SPIRO SCAN
K
85
2308
ST-460 SPIRO ANALYZER SPIROMETER
K
85
1620
SPIROMED 2
K
85
1277
MICROSPIRO-SDS
K
84
3841
ERGO-OXYSCREEN
K
84
4333
SPIROMETRICS 2451 & SMI I
K
84
4226
B-1000
K
84
3996
TURBOAIRE CHALLANGER ENVIRONMENTAL AIR CONTROLLER
K
84
3984
PM-80 PULMOTESTER
K
84
2536
CDX80
K
84
2372
SPIROMATE AS-500
K
84
0972
SPIROTECH ST-550
K
84
2041
PULMONARY FUNCTION SYSTEM
K
84
0929
FRC 85 SERIES SPIROMETER
K
84
0908
CHESTAC-25F SPIROMETER
K
83
2401
RESPIROMETER
K
83
1803
PULMOMETER
K
84
0741
PULMONARY FUNCTION TESTING STS
K
83
4475
RESPIRODYNE PULMONARY FUNCTION TEST
K
83
2432
SPIRO ANALYZER ST-100 AUTOMATIC SPIRO
K
83
2431
FUKUNDA SANGYA UNITS PULMOTESTER PM60
K
83
2430
FUKUNDA SANGYO UNITS ELECTRONIC SPIRO
K
83
2433
AUTOMATIC SPIROMETER ST-200
K
83
2185
OHIO MODEL 922 SPIROMETER
K
83
1497
SPIROMETRICS BREON 2400 & SMI 2400
K
82
3770
SPIROTECH ST-5500
K
82
2861
LIFELINE 4800-C DIGITAL SPIROMETER
K
82
0599
AUTOSPIROMETER HI-498
K
82
0032
VIT-O-METER
K
82
0036
CXD 400
K
81
2039
SPIROMETER 210/211
K
81
0437
BREATH METER
K
79
1422
MINISPIROMETER SP-1
K
79
1177
DISPIRO
K
78
0894
AIRFLOMETER
K
77
0928
PART NO. 66-00121
K
77
0927
PART NO. 66-00311
BZH
Meter, Peak Flow, Spirometry
BZK
Spirometer, Monitoring (W/Wo Alarm)
BZL
Computer, Oxygen-Uptake
BZM
Calculator, Pulmonary Function Interpretor (Diagnostic)
BZS
Stethoscope Head
BZT
Stethoscope, Esophageal, With Electrical Conductors
BZW
Stethoscope, Esophageal
CBQ
Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)
CBR
Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)
CBS
Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)
CBT
Arterial Blood Sampling Kit
CBZ
Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling
CCC
Analyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling
CCE
Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling
CCI
Analyzer, Gas, Nitrogen, Gaseous-Phase
CCJ
Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase
CCK
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
CCL
Analyzer, Gas, Oxygen, Gaseous-Phase
CCM
Plethysmograph, Pressure
JED
Analyzer, Oxyhemoglobin Concentration, Blood-Phase, Indwelling
JEF
Analyzer, Gas, Neon, Gaseous-Phase
JEG
Analyzer, Gas, Argon, Gaseous-Phase
JEH
Plethysmograph, Volume
JFE
Valve, Switching (Ploss)
KGK
Gas, Collecting Vessel
NHO
Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)
NHP
Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)
NHQ
Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)
OFZ
Blood Specimen Collection Kit (Excludes Hiv Testing)
PNV
Impedance Measuring Device Utilizing Oscillation Techniques
OGK
Orotracheal Intubation Guide Kit
PHZ
Abnormal Breath Sound Device
QEB
Ventilatory Electrical Impedance Tomograph
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
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-b—diagnostic-devices
/
BZG
/
K894556
View Source
SPIROTEQ
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K894556
510(k) Type
Traditional
Applicant
SYSTEM ANALYSIS CORP.
Country
France
FDA Decision
Substantially Equivalent
Decision Date
1/9/1990
Days to Decision
173 days