K852574 is an FDA 510(k) clearance for the WELCH ALLYN MODEL 40000 SPHYG W/ 40030-35 BLAD & C. 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 March 13, 1986, 268 days after receiving the submission on June 18, 1985.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1130.
| 510(k) Number | K852574 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 18, 1985 |
| Decision Date | March 13, 1986 |
| Days to Decision | 268 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DXN — System, Measurement, Blood-pressure, Non-invasive |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1130 |