The following data is part of a premarket notification filed by Preferred Medical Supply, Inc. with the FDA for Am-50 Aerosol/medication Air Compressor.
| Device ID | K945478 |
| 510k Number | K945478 |
| Device Name: | AM-50 AEROSOL/MEDICATION AIR COMPRESSOR |
| Classification | Compressor, Air, Portable |
| Applicant | PREFERRED MEDICAL SUPPLY, INC. 1574 KENMORE AVE. Buffalo, NY 14216 |
| Contact | Marc Sepanski |
| Correspondent | Marc Sepanski PREFERRED MEDICAL SUPPLY, INC. 1574 KENMORE AVE. Buffalo, NY 14216 |
| Product Code | BTI |
| CFR Regulation Number | 868.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-08 |
| Decision Date | 1995-09-28 |