510(k) K003770
K003770 is an FDA 510(k) premarket notification submitted by Bird Products Corp. for the device "BIRD TBIRD LEGACY VENTILATOR". The FDA issued a decision of ST on December 15, 2000. The device falls under product code CBK (Ventilator, Continuous, Facility Use), a Class II device regulated under 21 CFR 868.5895. Bird Products Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- ST ()
- Decision Date
- December 15, 2000
- Date Received
- December 6, 2000
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ventilator, Continuous, Facility Use
- Device Class
- Class II
- Regulation Number
- 868.5895
- Review Panel
- AN
- Submission Type