The following data is part of a premarket notification filed by Bird Products Corp. with the FDA for Bird Monitor Interface.
Device ID | K982580 |
510k Number | K982580 |
Device Name: | BIRD MONITOR INTERFACE |
Classification | Ventilator, Continuous, Facility Use |
Applicant | BIRD PRODUCTS CORP. 1100 BIRD CENTER DR. Palm Springs, CA 92262 |
Contact | Neil Battiste |
Correspondent | Neil Battiste BIRD PRODUCTS CORP. 1100 BIRD CENTER DR. Palm Springs, CA 92262 |
Product Code | CBK |
CFR Regulation Number | 868.5895 [🔎] |
Decision | Se Subject To Tracking Reg (ST) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-07-24 |
Decision Date | 1998-10-22 |
Summary: | summary |