FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AIRSEP NEWLIFE DUAL SIX OXYGEN CONCENTRATOR (MODIFICATION)
K Number: K960309
·
Decision Feb 28, 1997
Classifications
1
FEI Numbers
75
Registration Numbers
75
Same Product Code
273
Applicant Total
18
Review Days
420
Basic Information
- Device Name
- AIRSEP NEWLIFE DUAL SIX OXYGEN CONCENTRATOR (MODIFICATION)
- K Number
- K960309
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5440
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- AIRSEP CORP.
- Date Received
- January 5, 1996
- Decision Date
- February 28, 1997
- 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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