K901998 is an FDA 510(k) clearance for the DIGITAL MANOMETER (DM 50). This device is classified as a Meter, Airway Pressure (inspiratory Force) (Class II - Special Controls, product code BXR).
Submitted by Medical Support Products, Inc. (Lancaster, US). The FDA issued a Cleared decision on July 25, 1990, 84 days after receiving the submission on May 2, 1990.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1780.
| 510(k) Number | K901998 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 02, 1990 |
| Decision Date | July 25, 1990 |
| Days to Decision | 84 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | BXR — Meter, Airway Pressure (inspiratory Force) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1780 |