FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PORTABLE OXYGEN GENERATOR
K Number: K915381
·
Decision Mar 11, 1992
Classifications
1
FEI Numbers
83
Registration Numbers
83
Same Product Code
286
Applicant Total
24
Review Days
103
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Basic Information
- Device Name
- PORTABLE OXYGEN GENERATOR
- K Number
- K915381
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5440
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Aequitron Medical, Inc.
- Date Received
- November 29, 1991
- Decision Date
- March 11, 1992
- Product Code
- CAW
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| CAW | Generator, Oxygen, Portable | FDA class 2 | Anesthesiology |
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Other Clearances by Aequitron Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K961972 | MODEL AMI INFANT CENTRAL APHEA/HEART RATE MONITOR | Apr 18, 1997 | Substantially Equivalent - Subject to Tracking Reg. |
| K952880 | MODEL LP-1000 VOLUME VENTILATOR | Jun 20, 1996 | Substantially Equivalent - Subject to Tracking Reg. |
| K944654 | OXYGEN CONCENTRATION INDICATOR | Nov 8, 1994 | Substantially Equivalent |
| K914424 | MODEL 6213 REMOTE ALARM | Sep 10, 1992 | Substantially Equivalent |
| K911399 | NASAL CPAP (CONTINUOUS POSITIVE AIR PRESSURE SYST) | Sep 19, 1991 | Substantially Equivalent |
| K903020 | RESPIRATION/HEART RATE MONITOR MODEL 9500/9550 | Apr 10, 1991 | Substantially Equivalent |
| K905244 | MODEL LP6 VENTILATOR, MODIFICATION | Nov 30, 1990 | Substantially Equivalent |
| K903010 | CONTINUOUS VOLUME VENTILATOR MODEL LP10 | Nov 30, 1990 | Substantially Equivalent |
| K902785 | MODIFIED MODELS 9500,9550,9200,8200,HEART RATE MON | Jul 13, 1990 | Substantially Equivalent |
| K901656 | MODEL 9200 RESPIRATION/HEART RATE MONITOR | Jul 13, 1990 | Substantially Equivalent |