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 |