K925899 is an FDA 510(k) clearance for the AMBULATORY BLOOD PRESSURE MONITOR, MDL# 5100-01. This device is classified as a Computer, Blood-pressure (Class II - Special Controls, product code DSK).
Submitted by Welch Allyn, Inc. (Skaneateles Falls, US). The FDA issued a Cleared decision on May 21, 1993, 182 days after receiving the submission on November 20, 1992.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1110.
| 510(k) Number | K925899 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 20, 1992 |
| Decision Date | May 21, 1993 |
| Days to Decision | 182 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DSK — Computer, Blood-pressure |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1110 |