The following data is part of a premarket notification filed by Mercury Medical with the FDA for Mercury Airway Pressure Manometer.
| Device ID | K954486 |
| 510k Number | K954486 |
| Device Name: | MERCURY AIRWAY PRESSURE MANOMETER |
| Classification | Monitor, Airway Pressure (includes Gauge And/or Alarm) |
| 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 | CAP |
| CFR Regulation Number | 868.2600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-27 |
| Decision Date | 1996-04-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30641043553507 | K954486 | 000 |
| 30641043553521 | K954486 | 000 |
| 30641043553538 | K954486 | 000 |
| 30641043553545 | K954486 | 000 |
| 30641043553569 | K954486 | 000 |
| 30641043553576 | K954486 | 000 |
| 10641043553589 | K954486 | 000 |
| 30641043553590 | K954486 | 000 |
| 30641043553644 | K954486 | 000 |
| 30641043553651 | K954486 | 000 |
| 10641043553664 | K954486 | 000 |
| 30641043553675 | K954486 | 000 |
| 30641043553774 | K954486 | 000 |
| 30641043553781 | K954486 | 000 |
| 30641043553798 | K954486 | 000 |
| 30641043553811 | K954486 | 000 |
| 30641043553828 | K954486 | 000 |
| 30641043553514 | K954486 | 000 |