The following data is part of a premarket notification filed by Bear Medical Systems, Inc. with the FDA for Vhs 820 Humidifier, Modification.
| Device ID | K893034 |
| 510k Number | K893034 |
| Device Name: | VHS 820 HUMIDIFIER, MODIFICATION |
| Classification | Humidifier, Respiratory Gas, (direct Patient Interface) |
| Applicant | BEAR MEDICAL SYSTEMS, INC. 2085 RUSTIN AVE. Riverside, CA 92507 |
| Contact | Tony Wondka |
| Correspondent | Tony Wondka 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 | 1989-04-20 |
| Decision Date | 1989-07-14 |