510(k) K925422
K925422 is an FDA 510(k) premarket notification submitted by Bird Products Corp. for the device "BIRD 1000 PV PORTABLE VENTILATOR". The FDA issued a decision of Substantially Equivalent on May 13, 1993. The device falls under product code CBC (Bottle, Collection And Trap, Breathing System (Uncalibrated)), a Class II device regulated under 21 CFR 880.6740. Bird Products Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 13, 1993
- Date Received
- October 27, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bottle, Collection And Trap, Breathing System (Uncalibrated)
- Device Class
- Class II
- Regulation Number
- 880.6740
- Review Panel
- HO
- Submission Type