BUNN MODEL 50 OXYGEN FLOW CONTROLLER
FDA 510(k) clearance K883216 · decided 1988-08-18
Clearance details
- K-number
- K883216
- Device name
- BUNN MODEL 50 OXYGEN FLOW CONTROLLER
- Applicant
- The John Bunn Co.
- Decision
- Substantially Equivalent
- Date received
- 1988-07-29
- Decision date
- 1988-08-18
- Days to decision
- 20 days
- Clearance type
- Traditional
- Product code
- NFB
- Device class
- 2
- Regulation number
- 868.5905
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Tonawanda, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.