The following data is part of a premarket notification filed by Bird Products Corp. with the FDA for Partner Volume Monitor.
Device ID | K901885 |
510k Number | K901885 |
Device Name: | PARTNER VOLUME MONITOR |
Classification | Spirometer, Monitoring (w/wo Alarm) |
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 | BZK |
CFR Regulation Number | 868.1850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-04-26 |
Decision Date | 1990-09-27 |