K843969 is an FDA 510(k) clearance for the MODEL P23XL PHYSIOLOGICAL PRESSURE TRANSDUCER. This device is classified as a Transducer, Pressure, Catheter Tip (Class II - Special Controls, product code DXO).
Submitted by Gould, Inc. (Oxnard, US). The FDA issued a Cleared decision on January 23, 1985, 104 days after receiving the submission on October 11, 1984.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2870.
| 510(k) Number | K843969 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 11, 1984 |
| Decision Date | January 23, 1985 |
| Days to Decision | 104 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DXO — Transducer, Pressure, Catheter Tip |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2870 |