The following data is part of a premarket notification filed by Bear Medical Systems, Inc. with the FDA for Vaplok.
| Device ID | K864605 |
| 510k Number | K864605 |
| Device Name: | VAPLOK |
| Classification | Vaporizer, Anesthesia, Non-heated |
| Applicant | BEAR MEDICAL SYSTEMS, INC. 2085 RUSTIN AVE. Riverside, CA 92507 |
| Contact | Ray Pizinger |
| Correspondent | Ray Pizinger BEAR MEDICAL SYSTEMS, INC. 2085 RUSTIN AVE. Riverside, CA 92507 |
| Product Code | CAD |
| CFR Regulation Number | 868.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-11-24 |
| Decision Date | 1987-02-03 |