FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
5 LPM OXYGEN CONCENTRATOR
K Number: K953815
·
Decision Nov 9, 1995
Classifications
1
FEI Numbers
75
Registration Numbers
75
Same Product Code
273
Applicant Total
29
Review Days
87
Basic Information
- Device Name
- 5 LPM OXYGEN CONCENTRATOR
- K Number
- K953815
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5440
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- DEVILBISS HEALTH CARE, INC.
- Date Received
- August 14, 1995
- Decision Date
- November 9, 1995
- 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 DEVILBISS HEALTH CARE, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K963349 | DEVILBISS 8650D | Jun 13, 1997 | Substantially Equivalent |
| K970289 | COMPRESSOR/NEBULIZER #3650 | Apr 15, 1997 | Substantially Equivalent |
| K961126 | PULSE DOSE SERIES | Oct 21, 1996 | Substantially Equivalent |
| K950849 | MODEL #7354 | Feb 8, 1996 | Substantially Equivalent |
| K952491 | MODEL 7355 | Jan 31, 1996 | Substantially Equivalent |
| K952249 | JET NEBULIZER | Jan 30, 1996 | Substantially Equivalent |
| K952037 | 3 LPM OXYGEN CONCENTRATOR | Sep 6, 1995 | Substantially Equivalent |
| K946095 | DEVILBISS MODEL 5500 | Aug 24, 1995 | Substantially Equivalent |
| K944611 | MODEL# 7500 SURVEYOR | Apr 21, 1995 | Substantially Equivalent |
| K935979 | CONTINUOUS POSITIVE AIRWAY PRESSURE CPAP SYSTEM | Nov 10, 1994 | Substantially Equivalent |