The following data is part of a premarket notification filed by General Physiotherapy, Inc. with the FDA for Mist-ease Nebulizer.
| Device ID | K844591 |
| 510k Number | K844591 |
| Device Name: | MIST-EASE NEBULIZER |
| Classification | Nebulizer, Medicinal, Non-ventilatory (atomizer) |
| Applicant | GENERAL PHYSIOTHERAPY, INC. 1520 WASHINGTON AVE. St. Louis, MO 63103 |
| Contact | Thomas P Muchisky |
| Correspondent | Thomas P Muchisky GENERAL PHYSIOTHERAPY, INC. 1520 WASHINGTON AVE. St. Louis, MO 63103 |
| Product Code | CCQ |
| CFR Regulation Number | 868.5640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-11-26 |
| Decision Date | 1984-12-13 |