The following data is part of a premarket notification filed by Ambu, Inc. with the FDA for Ambu Disposable Pressure Manometer.
| Device ID | K040991 |
| 510k Number | K040991 |
| Device Name: | AMBU DISPOSABLE PRESSURE MANOMETER |
| Classification | Monitor, Airway Pressure (includes Gauge And/or Alarm) |
| Applicant | AMBU, INC. 611 NORTH HAMMONDS FERRY ROAD Linthicum, MD 21090 -1356 |
| Contact | Sanjay Parikh |
| Correspondent | Sanjay Parikh AMBU, INC. 611 NORTH HAMMONDS FERRY ROAD Linthicum, MD 21090 -1356 |
| Product Code | CAP |
| CFR Regulation Number | 868.2600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-16 |
| Decision Date | 2004-07-22 |