BEAR 7 VENTILATOR
FDA 510(k) clearance K912619 · decided 1992-06-11
Clearance details
- K-number
- K912619
- Device name
- BEAR 7 VENTILATOR
- Applicant
- Bear Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-06-13
- Decision date
- 1992-06-11
- Days to decision
- 364 days
- Clearance type
- Traditional
- Product code
- CBK
- Device class
- 2
- Regulation number
- 868.5895
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Riverside, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.