FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MASKA, OXYGEN VINYL D-SP. SINGLE USE
K Number: K760219
·
Decision Aug 3, 1976
Classifications
1
FEI Numbers
269
Registration Numbers
269
Same Product Code
54
Applicant Total
4
Review Days
22
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Basic Information
- Device Name
- MASKA, OXYGEN VINYL D-SP. SINGLE USE
- K Number
- K760219
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5580
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Manner Medical Products
- Date Received
- July 12, 1976
- Decision Date
- August 3, 1976
- Product Code
- BYG
- 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 |
|---|---|---|---|
| BYG | Mask, Oxygen | FDA class 1 | Anesthesiology |
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