FOME-CUF-WIRE RE-ENFORCED, AIRE-CUF WIRE
FDA 510(k) clearance K792035 · decided 1979-10-26
Clearance details
- K-number
- K792035
- Device name
- FOME-CUF-WIRE RE-ENFORCED, AIRE-CUF WIRE
- Applicant
- Bivona Medical Technologies
- Decision
- Substantially Equivalent
- Date received
- 1979-10-10
- Decision date
- 1979-10-26
- Days to decision
- 16 days
- Clearance type
- Traditional
- Product code
- BTR
- Device class
- 2
- Regulation number
- 868.5730
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.