TBIRD VS/AVS VOLUME VENTILATOR, MODELS 15568, 15570 , LP10 VOLUME VENTILATOR WITH PRESSURE LIMIT MODEL 00-004130, BEAR 3
FDA 510(k) clearance K981971 · decided 1998-08-24
Clearance details
- K-number
- K981971
- Device name
- TBIRD VS/AVS VOLUME VENTILATOR, MODELS 15568, 15570 , LP10 VOLUME VENTILATOR WITH PRESSURE LIMIT MODEL 00-004130, BEAR 3
- Applicant
- Bird Products Corp.
- Decision
- Substantially Equivalent - Subject to Tracking Reg.
- Date received
- 1998-06-04
- Decision date
- 1998-08-24
- Days to decision
- 81 days
- Clearance type
- Traditional
- Product code
- CBK
- Device class
- 2
- Regulation number
- 868.5895
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Palm Spring, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.