FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MOBILAIRE, PLA-01 OXYGEN CONCENTRATOR
K Number: K851439
·
Decision Jul 29, 1985
Classifications
1
FEI Numbers
75
Registration Numbers
75
Same Product Code
273
Applicant Total
111
Review Days
110
Basic Information
- Device Name
- MOBILAIRE, PLA-01 OXYGEN CONCENTRATOR
- K Number
- K851439
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5440
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- INVACARE CORP.
- Date Received
- April 10, 1985
- Decision Date
- July 29, 1985
- 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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