K780043 is an FDA 510(k) clearance for the ESIS MODULE. This device is classified as a Amplifier And Signal Conditioner, Biopotential (Class II - Special Controls, product code DRR).
Submitted by Datascope Corp. (Mchenry, US). The FDA issued a Cleared decision on February 13, 1978, 35 days after receiving the submission on January 9, 1978.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2050.
| 510(k) Number | K780043 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 09, 1978 |
| Decision Date | February 13, 1978 |
| Days to Decision | 35 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | - |
| Product Code | DRR - Amplifier And Signal Conditioner, Biopotential |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2050 |