FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MASK, OXYGEN, NONBREATHING
K Number: K781414
·
Decision Sep 7, 1978
Classifications
1
FEI Numbers
151
Registration Numbers
151
Same Product Code
12
Applicant Total
4
Review Days
23
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- MASK, OXYGEN, NONBREATHING
- K Number
- K781414
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5570
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Vitalab Products Corp.
- Date Received
- August 15, 1978
- Decision Date
- September 7, 1978
- Product Code
- KGB
- 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 |
|---|---|---|---|
| KGB | Mask, Oxygen, Non-Rebreathing | FDA class 1 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KGB), ordered by most recent decision date.
POCKET RESCUE
FDA 510(k)
FDA Class 1
·Anesthesiology
ULTIMATE SEAL
FDA 510(k)
FDA Class 1
·Anesthesiology
COMBO MASK
FDA 510(k)
FDA Class 1
·Anesthesiology
CHALLENGE POWDER-FREE, HYPOALLERGENIC, SYNTHETIC SURGICAL GLOVES
FDA 510(k)
FDA Class 1
·Anesthesiology
COMPACT MASK
FDA 510(k)
FDA Class 1
·Anesthesiology
NONREBREATHING VALVE
FDA 510(k)
FDA Class 1
·Anesthesiology