K093907 is an FDA 510(k) clearance for the WELCH ALLYN NON INVASIVE BLOOD PRESSURE (NIBP) DEVICE. This device is classified as a System, Measurement, Blood-pressure, Non-invasive (Class II — Special Controls, product code DXN).
Submitted by Welch Allyn, Inc. (Skaneateles Falls, US). The FDA issued a Cleared decision on April 14, 2010, 113 days after receiving the submission on December 22, 2009.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1130.
| 510(k) Number | K093907 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 22, 2009 |
| Decision Date | April 14, 2010 |
| Days to Decision | 113 days |
| Submission Type | Abbreviated |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DXN — System, Measurement, Blood-pressure, Non-invasive |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.1130 |