K041778 is an FDA 510(k) clearance for the REIZEN TALKING BLOOD PRESSURE MONITOR, MODEL #SF860T. This device is classified as a System, Measurement, Blood-pressure, Non-invasive (Class II - Special Controls, product code DXN).
Submitted by Maxi-Aids, Inc. (Farmingdale, US). The FDA issued a Cleared decision on August 31, 2004, 61 days after receiving the submission on July 1, 2004.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1130.
| 510(k) Number | K041778 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 01, 2004 |
| Decision Date | August 31, 2004 |
| Days to Decision | 61 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 |