FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MASK, PXYGEN
K Number: K781413
·
Decision Sep 7, 1978
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
47
Applicant Total
4
Review Days
23
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Basic Information
- Device Name
- MASK, PXYGEN
- K Number
- K781413
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2120
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Vitalab Products Corp.
- Date Received
- August 15, 1978
- Decision Date
- September 7, 1978
- Product Code
- DPT
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DPT | Probe, Blood-Flow, Extravascular | FDA class 2 | Cardiovascular |
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