The following data is part of a premarket notification filed by Bear Medical Systems, Inc. with the FDA for Bear Jet 150 Ventilator.
| Device ID | K830165 |
| 510k Number | K830165 |
| Device Name: | BEAR JET 150 VENTILATOR |
| Classification | Cabinet, Ethylene-oxide Gas Aerator |
| Applicant | BEAR MEDICAL SYSTEMS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | FLI |
| CFR Regulation Number | 880.6100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-01-18 |
| Decision Date | 1983-04-12 |