The following data is part of a premarket notification filed by Mercury Ent., Inc. D/b/a Mercury Medical with the FDA for Mercury Expiratory Resistance Exerciser.
| Device ID | K942919 |
| 510k Number | K942919 |
| Device Name: | MERCURY EXPIRATORY RESISTANCE EXERCISER |
| Classification | Spirometer, Therapeutic (incentive) |
| Applicant | MERCURY ENT., INC. D/B/A MERCURY MEDICAL 11300 A-49TH.STREET NORTH Clearwater, FL 34622 -4800 |
| Contact | Kathy L Hann |
| Correspondent | Kathy L Hann MERCURY ENT., INC. D/B/A MERCURY MEDICAL 11300 A-49TH.STREET 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 | 1994-06-21 |
| Decision Date | 1994-09-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30641043370012 | K942919 | 000 |
| 10641043370001 | K942919 | 000 |