K761017 is an FDA 510(k) clearance for the PRESSURE MODULE (MODEL P3). This device is classified as a Amplifier And Signal Conditioner, Transducer Signal (Class II - Special Controls, product code DRQ).
Submitted by Datascope Corp. (Mchenry, US). The FDA issued a Cleared decision on November 15, 1976, 5 days after receiving the submission on November 10, 1976.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2060.
| 510(k) Number | K761017 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 10, 1976 |
| Decision Date | November 15, 1976 |
| Days to Decision | 5 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | - |
| Product Code | DRQ - Amplifier And Signal Conditioner, Transducer Signal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2060 |