The following data is part of a premarket notification filed by Bear Medical Systems, Inc. with the FDA for Bear 1000, Veolar W Leonardo Graphics, Bicore Cp-2000, Bicore Cp-100, Hi-lo Jet Et Tube.
| Device ID | K983981 |
| 510k Number | K983981 |
| Device Name: | BEAR 1000, VEOLAR W LEONARDO GRAPHICS, BICORE CP-2000, BICORE CP-100, HI-LO JET ET TUBE |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | BEAR MEDICAL SYSTEMS, INC. 1100 BIRD CENTER DR. Palm Springs, CA 92262 |
| Contact | Darryl Shelby |
| Correspondent | Darryl Shelby BEAR MEDICAL SYSTEMS, INC. 1100 BIRD CENTER DR. Palm Springs, CA 92262 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-09 |
| Decision Date | 1998-11-20 |
| Summary: | summary |