The following data is part of a premarket notification filed by Bird Products Corp. with the FDA for V.i.p. Bird Infant - Pediatric Ventilator.
Device ID | K895541 |
510k Number | K895541 |
Device Name: | V.I.P. BIRD INFANT - PEDIATRIC VENTILATOR |
Classification | Ventilator, Continuous, Facility Use |
Applicant | BIRD PRODUCTS CORP. 1100 BIRD CENTER DR. Palm Springs, CA 92262 |
Contact | W. C Bentinck |
Correspondent | W. C Bentinck BIRD PRODUCTS CORP. 1100 BIRD CENTER DR. Palm Springs, CA 92262 |
Product Code | CBK |
CFR Regulation Number | 868.5895 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-09-13 |
Decision Date | 1990-03-08 |