The following data is part of a premarket notification filed by Aqua-air Medical Devices, Inc. with the FDA for The Aqua-air Professional Field Unit(s).
| Device ID | K950175 |
| 510k Number | K950175 |
| Device Name: | THE AQUA-AIR PROFESSIONAL FIELD UNIT(S) |
| Classification | Unit, Operative Dental |
| Applicant | AQUA-AIR MEDICAL DEVICES, INC. 3275 N.W. 28TH ST. Miami, FL 33142 |
| Contact | Philip M Hall |
| Correspondent | Philip M Hall AQUA-AIR MEDICAL DEVICES, INC. 3275 N.W. 28TH ST. Miami, FL 33142 |
| Product Code | EIA |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-01-17 |
| Decision Date | 1995-04-18 |