The following data is part of a premarket notification filed by Bear Medical Systems, Inc. with the FDA for Air Compressor.
| Device ID | K850795 |
| 510k Number | K850795 |
| Device Name: | AIR COMPRESSOR |
| Classification | Compressor, Air, Portable |
| Applicant | BEAR MEDICAL SYSTEMS, INC. TIMETER INSTRUMENTS CORP. 2501 OREGON PIKE Lancaster, PA 17601 |
| Contact | Terry L Landis |
| Correspondent | Terry L Landis BEAR MEDICAL SYSTEMS, INC. TIMETER INSTRUMENTS CORP. 2501 OREGON PIKE Lancaster, PA 17601 |
| Product Code | BTI |
| CFR Regulation Number | 868.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-02-07 |
| Decision Date | 1985-05-28 |