K040991 is an FDA 510(k) clearance for the AMBU DISPOSABLE PRESSURE MANOMETER. This device is classified as a Monitor, Airway Pressure (includes Gauge And/or Alarm) (Class II - Special Controls, product code CAP).
Submitted by Ambu, Inc. (Linthicum, US). The FDA issued a Cleared decision on July 22, 2004, 97 days after receiving the submission on April 16, 2004.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.2600.
| 510(k) Number | K040991 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 16, 2004 |
| Decision Date | July 22, 2004 |
| Days to Decision | 97 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | CAP — Monitor, Airway Pressure (includes Gauge And/or Alarm) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.2600 |