The following data is part of a premarket notification filed by Mercury Medical with the FDA for Mercury Medical Negative Inspiratory Force (nif) Disposable Monometer.
| Device ID | K032593 |
| 510k Number | K032593 |
| Device Name: | MERCURY MEDICAL NEGATIVE INSPIRATORY FORCE (NIF) DISPOSABLE MONOMETER |
| Classification | Meter, Airway Pressure (inspiratory Force) |
| Applicant | MERCURY MEDICAL 11300 49TH ST. NORTH Clearwater, FL 33762 -4800 |
| Contact | Wayne Glover |
| Correspondent | Wayne Glover MERCURY MEDICAL 11300 49TH ST. NORTH Clearwater, FL 33762 -4800 |
| Product Code | BXR |
| CFR Regulation Number | 868.1780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-08-22 |
| Decision Date | 2004-02-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30641043340039 | K032593 | 000 |
| 30641043340022 | K032593 | 000 |
| 10641043340011 | K032593 | 000 |
| 30641043340008 | K032593 | 000 |