The following data is part of a premarket notification filed by Bear Medical Systems, Inc. with the FDA for Bear Vh-820 Humidifier.
Device ID | K873634 |
510k Number | K873634 |
Device Name: | BEAR VH-820 HUMIDIFIER |
Classification | Humidifier, Respiratory Gas, (direct Patient Interface) |
Applicant | BEAR MEDICAL SYSTEMS, INC. 2085 RUSTIN AVE. Riverside, CA 92507 |
Contact | Mike Collins |
Correspondent | Mike Collins BEAR MEDICAL SYSTEMS, INC. 2085 RUSTIN AVE. Riverside, CA 92507 |
Product Code | BTT |
CFR Regulation Number | 868.5450 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-09-09 |
Decision Date | 1987-12-02 |