The following data is part of a premarket notification filed by Mercury Medical with the FDA for Mercury Medical Expiratory Resistance Exerciser, Resistex.
| Device ID | K954492 |
| 510k Number | K954492 |
| Device Name: | MERCURY MEDICAL EXPIRATORY RESISTANCE EXERCISER, RESISTEX |
| Classification | Spirometer, Therapeutic (incentive) |
| Applicant | MERCURY MEDICAL 11300-A 49TH ST. NORTH Clearwater, FL 34622 -4800 |
| Contact | Kathy L Hann |
| Correspondent | Kathy L Hann MERCURY MEDICAL 11300-A 49TH ST. NORTH Clearwater, FL 34622 -4800 |
| Product Code | BWF |
| CFR Regulation Number | 868.5690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-27 |
| Decision Date | 1996-10-21 |
| Summary: | summary |