The following data is part of a premarket notification filed by Precision Medical, Inc. with the FDA for Precision Mist Compressor.
| Device ID | K923324 |
| 510k Number | K923324 |
| Device Name: | PRECISION MIST COMPRESSOR |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | PRECISION MEDICAL, INC. 300 HELD DR. Northampton, PA 18067 |
| Contact | Clyde Shuman |
| Correspondent | Clyde Shuman PRECISION MEDICAL, INC. 300 HELD DR. Northampton, PA 18067 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-07 |
| Decision Date | 1993-01-14 |