FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODEL 379 WXYGEN CONCENTRATOR
K Number: K801523
·
Decision Jul 14, 1980
Classifications
1
FEI Numbers
83
Registration Numbers
83
Same Product Code
286
Applicant Total
2
Review Days
13
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Basic Information
- Device Name
- MODEL 379 WXYGEN CONCENTRATOR
- K Number
- K801523
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5440
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Stanley Aviation Corp.
- Date Received
- July 1, 1980
- Decision Date
- July 14, 1980
- 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 Stanley Aviation Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K811702 | MODEL 381 HOME OXYGEN SENTRY | Jul 16, 1981 | Substantially Equivalent |