K972020 is an FDA 510(k) clearance for the OSCILLOMATE NON-INVASIVE BLOOD PRESSURE MONITOR. This device is classified as a System, Phonocatheter, Intracavitary (Class II - Special Controls, product code DXW).
Submitted by Cas Medical Systems, Inc. (Branford, US). The FDA issued a Cleared decision on May 5, 1998, 337 days after receiving the submission on June 2, 1997.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1270.
| 510(k) Number | K972020 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 02, 1997 |
| Decision Date | May 05, 1998 |
| Days to Decision | 337 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DXW - System, Phonocatheter, Intracavitary |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1270 |