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
Subpart G—Miscellaneous
CFR Sub-Part
BRX
Stool, Anesthesia
1
Product Code
BRY
Cabinet, Table And Tray, Anesthesia
1
Product Code
BSY
Catheters, Suction, Tracheobronchial
1
Product Code
BTI
Compressor, Air, Portable
2
Product Code
K
13
1881
OMBRA TABLE TOP COMPRESSOR
2
Cleared 510(K)
K
11
3338
MEDICAL AIR COMPRESSOR
2
Cleared 510(K)
K
09
1871
DK50 DS
2
Cleared 510(K)
K
07
2634
EMG TRITON -COMP,MODEL NCA01-XXX SERIES
2
Cleared 510(K)
K
06
0781
MEDICAL COMPRESSOR, MODELS DK50 D AND DM
2
Cleared 510(K)
K
05
1691
MINIMATE COMPRESSOR
2
Cleared 510(K)
K
04
1781
VENTILAIR II MEDICAL AIR COMPRESSOR
2
Cleared 510(K)
K
04
1406
NEWPORT C250 AIR COMPRESSOR MODEL C250
2
Cleared 510(K)
K
04
1974
MED2000 NEBULIZER COMPRESSOR, MODELS P3, P4, P5 WITH NEBULIZER
2
Cleared 510(K)
K
04
0220
MEDICAL AIR COMPRESSOR
2
Cleared 510(K)
K
03
1686
AEROMIST LT, MODEL HCS15004
2
Cleared 510(K)
K
03
1413
VIGORMIST COMPRESSOR NEBULIZER
2
Cleared 510(K)
K
02
3354
COMPRESSOR MINI, 115 V, MODEL 64 81 779 EH81E
2
Cleared 510(K)
K
02
0797
PULMO-MIST COMPRESSOR MODEL # 4323
2
Cleared 510(K)
K
01
3027
MISTER NEB NEBULIZER COMPRESSOR, WITH NEBULIZER, MODEL HS123
2
Cleared 510(K)
K
00
2862
PRONEB ULTRA MODEL NUMBER 85B0100
2
Cleared 510(K)
K
00
2468
SAN UP S.A. NEBULIZER COMPRESSOR, WITH DISPOSABLE NEBULIZER, MODEL 3050
2
Cleared 510(K)
K
98
2789
MEDICAL AIR COMPRESSOR, MODEL # 8413419
2
Cleared 510(K)
K
96
3349
DEVILBISS 8650D
2
Cleared 510(K)
K
95
1926
ALRECO 40400
2
Cleared 510(K)
K
94
5478
AM-50 AEROSOL/MEDICATION AIR COMPRESSOR
2
Cleared 510(K)
K
95
2616
MICROTIME
2
Cleared 510(K)
K
94
6039
MODEL #5000 PULMO PLUS
2
Cleared 510(K)
K
94
0630
503 MAXI COMPRESSOR
2
Cleared 510(K)
K
93
0509
PM PUMP COMPRESSOR
2
Cleared 510(K)
K
92
5010
NEBULIZER PUMP, POWERED, MODEL 1110
2
Cleared 510(K)
K
92
5011
NEBULIZER PUMP, POWERED MODEL 1180
2
Cleared 510(K)
K
93
1015
DEVILBISS MODEL 4650 COMPRESSOR NEUBULIZER
2
Cleared 510(K)
K
91
3097
SAM ST
2
Cleared 510(K)
K
92
2623
NEBULIZER SYSTEM
2
Cleared 510(K)
K
92
0954
AIR STAR
2
Cleared 510(K)
K
90
2520
AIR PLUS NEBULIZER
2
Cleared 510(K)
K
90
4045
#504 MINI COMPRESSOR
2
Cleared 510(K)
K
90
2184
MAXI ASPIRATOR
2
Cleared 510(K)
K
90
2762
PM14 SOFT AIR COMPRESSOR
2
Cleared 510(K)
K
90
0686
MAXI COMPRESSORS
2
Cleared 510(K)
K
89
4831
PORTABLE AIR COMPRESSOR MODEL NUMBER 8125
2
Cleared 510(K)
K
88
3829
TURBO AIR COMPRESSOR 8000
2
Cleared 510(K)
K
88
4722
LUMINEB I
2
Cleared 510(K)
K
88
3704
MULTIICHALLENGE NEBULIZER SYSTEM
2
Cleared 510(K)
K
88
3132
NEBULIZER PUMP POWERED MODELS 020 AND 050
2
Cleared 510(K)
K
87
3677
ECONO-MIST PORTABLE COMPRESSOR DRIVEN NEBULIZER
2
Cleared 510(K)
K
87
1829
SIEMENS DRY AIR COMPRESSOR
2
Cleared 510(K)
K
87
0428
AEROSOL ONE, NEBULIZER PUMP
2
Cleared 510(K)
K
86
4547
BIRD 6500 AIR COMPRESSOR
2
Cleared 510(K)
K
86
4680
MOBIL 02
2
Cleared 510(K)
K
86
3339
DURA NEB(TM) 2000 PORTABLE COMPRESSOR
2
Cleared 510(K)
K
86
2628
BUNN MODEL 510 MEDICATION COMPRESSOR
2
Cleared 510(K)
K
86
1865
ERIE-NEB
2
Cleared 510(K)
K
85
2622
AEROSOL ONE
2
Cleared 510(K)
K
85
4747
TRAVONEB MODEL # TONE 1
2
Cleared 510(K)
K
85
3944
CPAP BLOWER
2
Cleared 510(K)
K
85
4306
OHMEDA CPU AIR COMPRESSOR MODEL 3350
2
Cleared 510(K)
K
85
0795
AIR COMPRESSOR
2
Cleared 510(K)
K
84
4956
AVA-MIST PORTABLE AIR COMPRESSOR
2
Cleared 510(K)
K
84
1537
IMPACT MODEL 601
2
Cleared 510(K)
K
83
3501
MEDI-MIST PORTA. COMPRESSOR DRIVEN
2
Cleared 510(K)
K
83
2220
TRAVELER NEBULIZING SYSTEM
2
Cleared 510(K)
K
83
2072
VITA-MIST AIR COMPRESSOR & NEBULIZER
2
Cleared 510(K)
K
83
0417
RESPI-NEB-AEROSOL SYSTEM
2
Cleared 510(K)
K
82
2685
NEB-TRAVEL NTS-1000 & NTS-3000 THERAPY
2
Cleared 510(K)
K
82
2512
REPCO EASY-BREATHER CLINICAL AIR PUMP
2
Cleared 510(K)
K
82
0079
AIRMED PNEUMATIC EQUIP. FILTRA/CONTROL
2
Cleared 510(K)
K
81
3311
COMPRESSOR, AIR, PORTABLE
2
Cleared 510(K)
K
81
2766
PCS-5 ACCESSORIES
2
Cleared 510(K)
K
81
2767
SNIFF AIR COMPRESSOR #SF-6
2
Cleared 510(K)
K
80
2253
AIR COMPRESSOR ADAPTOR KIT
2
Cleared 510(K)
K
80
1286
PORTA-NEB(R) 310
2
Cleared 510(K)
K
80
0534
MODEL 52 BUNN DRY AIR SUPPLY
2
Cleared 510(K)
K
79
2457
COMPRESSOR
2
Cleared 510(K)
K
79
0912
ARIDYNE 3500
2
Cleared 510(K)
K
78
1213
COMPRESSOR, AIR, MINI-SILENT
2
Cleared 510(K)
K
77
1707
ADIDYNE 3000
2
Cleared 510(K)
K
76
1294
RESPIRATORY BLOWER
2
Cleared 510(K)
BXJ
Clip, Nose
1
Product Code
BXK
Gas, Calibration (Specified Concentration)
1
Product Code
BZN
Cart, Emergency, Cardiopulmonary (Excluding Equipment)
1
Product Code
CAM
Yoke Assembly, Medical Gas
1
Product Code
CCX
Support, Patient Position
1
Product Code
OFO
Airway Suction Kit
1
Product Code
OFR
Tracheobronchial Suction Catheter Kit
1
Product Code
OFS
Tracheal Suction Set
1
Product Code
OYI
Non-Bronchoscopic Bronchoalveolar Lavage Catheter
1
Product Code
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-g—miscellaneous
/
BTI
/
K023354
View Source
COMPRESSOR MINI, 115 V, MODEL 64 81 779 EH81E
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K023354
510(k) Type
Traditional
Applicant
SIEMENS ELEMA AB
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/5/2003
Days to Decision
333 days
Submission Type
Summary
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
Subpart G—Miscellaneous
BRX
Stool, Anesthesia
BRY
Cabinet, Table And Tray, Anesthesia
BSY
Catheters, Suction, Tracheobronchial
BTI
Compressor, Air, Portable
K
13
1881
OMBRA TABLE TOP COMPRESSOR
K
11
3338
MEDICAL AIR COMPRESSOR
K
09
1871
DK50 DS
K
07
2634
EMG TRITON -COMP,MODEL NCA01-XXX SERIES
K
06
0781
MEDICAL COMPRESSOR, MODELS DK50 D AND DM
K
05
1691
MINIMATE COMPRESSOR
K
04
1781
VENTILAIR II MEDICAL AIR COMPRESSOR
K
04
1406
NEWPORT C250 AIR COMPRESSOR MODEL C250
K
04
1974
MED2000 NEBULIZER COMPRESSOR, MODELS P3, P4, P5 WITH NEBULIZER
K
04
0220
MEDICAL AIR COMPRESSOR
K
03
1686
AEROMIST LT, MODEL HCS15004
K
03
1413
VIGORMIST COMPRESSOR NEBULIZER
K
02
3354
COMPRESSOR MINI, 115 V, MODEL 64 81 779 EH81E
K
02
0797
PULMO-MIST COMPRESSOR MODEL # 4323
K
01
3027
MISTER NEB NEBULIZER COMPRESSOR, WITH NEBULIZER, MODEL HS123
K
00
2862
PRONEB ULTRA MODEL NUMBER 85B0100
K
00
2468
SAN UP S.A. NEBULIZER COMPRESSOR, WITH DISPOSABLE NEBULIZER, MODEL 3050
K
98
2789
MEDICAL AIR COMPRESSOR, MODEL # 8413419
K
96
3349
DEVILBISS 8650D
K
95
1926
ALRECO 40400
K
94
5478
AM-50 AEROSOL/MEDICATION AIR COMPRESSOR
K
95
2616
MICROTIME
K
94
6039
MODEL #5000 PULMO PLUS
K
94
0630
503 MAXI COMPRESSOR
K
93
0509
PM PUMP COMPRESSOR
K
92
5010
NEBULIZER PUMP, POWERED, MODEL 1110
K
92
5011
NEBULIZER PUMP, POWERED MODEL 1180
K
93
1015
DEVILBISS MODEL 4650 COMPRESSOR NEUBULIZER
K
91
3097
SAM ST
K
92
2623
NEBULIZER SYSTEM
K
92
0954
AIR STAR
K
90
2520
AIR PLUS NEBULIZER
K
90
4045
#504 MINI COMPRESSOR
K
90
2184
MAXI ASPIRATOR
K
90
2762
PM14 SOFT AIR COMPRESSOR
K
90
0686
MAXI COMPRESSORS
K
89
4831
PORTABLE AIR COMPRESSOR MODEL NUMBER 8125
K
88
3829
TURBO AIR COMPRESSOR 8000
K
88
4722
LUMINEB I
K
88
3704
MULTIICHALLENGE NEBULIZER SYSTEM
K
88
3132
NEBULIZER PUMP POWERED MODELS 020 AND 050
K
87
3677
ECONO-MIST PORTABLE COMPRESSOR DRIVEN NEBULIZER
K
87
1829
SIEMENS DRY AIR COMPRESSOR
K
87
0428
AEROSOL ONE, NEBULIZER PUMP
K
86
4547
BIRD 6500 AIR COMPRESSOR
K
86
4680
MOBIL 02
K
86
3339
DURA NEB(TM) 2000 PORTABLE COMPRESSOR
K
86
2628
BUNN MODEL 510 MEDICATION COMPRESSOR
K
86
1865
ERIE-NEB
K
85
2622
AEROSOL ONE
K
85
4747
TRAVONEB MODEL # TONE 1
K
85
3944
CPAP BLOWER
K
85
4306
OHMEDA CPU AIR COMPRESSOR MODEL 3350
K
85
0795
AIR COMPRESSOR
K
84
4956
AVA-MIST PORTABLE AIR COMPRESSOR
K
84
1537
IMPACT MODEL 601
K
83
3501
MEDI-MIST PORTA. COMPRESSOR DRIVEN
K
83
2220
TRAVELER NEBULIZING SYSTEM
K
83
2072
VITA-MIST AIR COMPRESSOR & NEBULIZER
K
83
0417
RESPI-NEB-AEROSOL SYSTEM
K
82
2685
NEB-TRAVEL NTS-1000 & NTS-3000 THERAPY
K
82
2512
REPCO EASY-BREATHER CLINICAL AIR PUMP
K
82
0079
AIRMED PNEUMATIC EQUIP. FILTRA/CONTROL
K
81
3311
COMPRESSOR, AIR, PORTABLE
K
81
2766
PCS-5 ACCESSORIES
K
81
2767
SNIFF AIR COMPRESSOR #SF-6
K
80
2253
AIR COMPRESSOR ADAPTOR KIT
K
80
1286
PORTA-NEB(R) 310
K
80
0534
MODEL 52 BUNN DRY AIR SUPPLY
K
79
2457
COMPRESSOR
K
79
0912
ARIDYNE 3500
K
78
1213
COMPRESSOR, AIR, MINI-SILENT
K
77
1707
ADIDYNE 3000
K
76
1294
RESPIRATORY BLOWER
BXJ
Clip, Nose
BXK
Gas, Calibration (Specified Concentration)
BZN
Cart, Emergency, Cardiopulmonary (Excluding Equipment)
CAM
Yoke Assembly, Medical Gas
CCX
Support, Patient Position
OFO
Airway Suction Kit
OFR
Tracheobronchial Suction Catheter Kit
OFS
Tracheal Suction Set
OYI
Non-Bronchoscopic Bronchoalveolar Lavage Catheter
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-g—miscellaneous
/
BTI
/
K023354
View Source
COMPRESSOR MINI, 115 V, MODEL 64 81 779 EH81E
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K023354
510(k) Type
Traditional
Applicant
SIEMENS ELEMA AB
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/5/2003
Days to Decision
333 days
Submission Type
Summary