K832897 is an FDA 510(k) clearance for the MODEL TTPM TIME TEMP. PRESSURE MONITOR. This device is classified as a Transducer, Blood-pressure, Extravascular (Class II — Special Controls, product code DRS).
Submitted by Electromedics, Inc. (Walker, US). The FDA issued a Cleared decision on March 22, 1984, 213 days after receiving the submission on August 22, 1983.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2850.
| 510(k) Number | K832897 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 22, 1983 |
| Decision Date | March 22, 1984 |
| Days to Decision | 213 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DRS — Transducer, Blood-pressure, Extravascular |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.2850 |