K781680 is an FDA 510(k) clearance for the MONITORING, PRESSURE KIT. This device is classified as a Transducer, Blood-pressure, Extravascular (Class II - Special Controls, product code DRS).
Submitted by Pharmaseal Div., Baxter Healthcare Corp. (Mchenry, US). The FDA issued a Cleared decision on October 6, 1978, 4 days after receiving the submission on October 2, 1978.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2850.
| 510(k) Number | K781680 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 02, 1978 |
| Decision Date | October 06, 1978 |
| Days to Decision | 4 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 |