FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
OXYGEN MASK, AIR-ENTRAINMENT
K Number: K772127
·
Decision Jan 3, 1978
Classifications
1
FEI Numbers
95
Registration Numbers
95
Same Product Code
18
Applicant Total
48
Review Days
53
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Basic Information
- Device Name
- OXYGEN MASK, AIR-ENTRAINMENT
- K Number
- K772127
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5600
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Salter Labs
- Date Received
- November 11, 1977
- Decision Date
- January 3, 1978
- Product Code
- BYF
- 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 |
|---|---|---|---|
| BYF | Mask, Oxygen, Low Concentration, Venturi | FDA class 1 | Anesthesiology |
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