K831698 is an FDA 510(k) clearance for the DISPOSABLE PRESSURE TRANSDUCER#14004195. This device is classified as a Transducer, Blood-pressure, Extravascular (Class II - Special Controls, product code DRS).
Submitted by Norton Performance Plastics Corp. (Mchenry, US). The FDA issued a Cleared decision on August 11, 1983, 78 days after receiving the submission on May 25, 1983.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2850.
| 510(k) Number | K831698 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 25, 1983 |
| Decision Date | August 11, 1983 |
| Days to Decision | 78 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 |