K001670 is an FDA 510(k) clearance for the AUTOMATIC BLOOD PRESSURE MONITOR WITH INTELLISENSE, MODEL HEM-757. This device is classified as a System, Measurement, Blood-pressure, Non-invasive (Class II - Special Controls, product code DXN).
Submitted by Omron Healthcare, Inc. (Vernon Hills, US). The FDA issued a Cleared decision on June 30, 2000, 29 days after receiving the submission on June 1, 2000.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1130.
| 510(k) Number | K001670 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 01, 2000 |
| Decision Date | June 30, 2000 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| Product Code | DXN — System, Measurement, Blood-pressure, Non-invasive |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1130 |