FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SYSTEM ONE OXYGEN CONCENTRATOR
K Number: K821393
·
Decision Aug 10, 1982
Classifications
1
FEI Numbers
83
Registration Numbers
83
Same Product Code
286
Applicant Total
3
Review Days
91
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Basic Information
- Device Name
- SYSTEM ONE OXYGEN CONCENTRATOR
- K Number
- K821393
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5440
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Marathon
- Date Received
- May 11, 1982
- Decision Date
- August 10, 1982
- 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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