FDA 510(k)
FDA class 2
Substantially Equivalent - Subject to Tracking Reg.
🇺🇸 United States
TBIRD VS/AVS VOLUME VENTILATOR, MODELS 15568, 15570 , LP10 VOLUME VENTILATOR WITH PRESSURE LIMIT MODEL 00-004130, BEAR 3
K Number: K981971
·
Decision Aug 24, 1998
Classifications
1
FEI Numbers
130
Registration Numbers
130
Same Product Code
504
Applicant Total
35
Review Days
81
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Basic Information
- Device Name
- TBIRD VS/AVS VOLUME VENTILATOR, MODELS 15568, 15570 , LP10 VOLUME VENTILATOR WITH PRESSURE LIMIT MODEL 00-004130, BEAR 3
- K Number
- K981971
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5895
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent - Subject to Tracking Reg.
- Applicant
- Bird Products Corp.
- Date Received
- June 4, 1998
- Decision Date
- August 24, 1998
- Product Code
- CBK
- 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 |
|---|---|---|---|
| CBK | Ventilator, Continuous, Facility Use | FDA class 2 | Anesthesiology |
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| K990856 | HERITAGE NASAL CPAP SYSTEM, MODEL P/N 15682 | Jan 11, 2000 | Substantially Equivalent |
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| K982580 | BIRD MONITOR INTERFACE | Oct 22, 1998 | Substantially Equivalent - Subject to Tracking Reg. |
| K973646 | BIRD SENTRY BLENDER/ ANALYZER / BIRD SENTRY LOW FLOW BLENDER/ANALYZER | May 7, 1998 | Substantially Equivalent |