K934887 is an FDA 510(k) clearance for the 9750 ATHENA ETHERNET OPTION. This device is classified as a Echocardiograph (Class II - Special Controls, product code DXK).
Submitted by S & W Medico Teknik A/S (Albertslund, DK). The FDA issued a Cleared decision on January 14, 1994, 94 days after receiving the submission on October 12, 1993.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2330.
| 510(k) Number | K934887 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 12, 1993 |
| Decision Date | January 14, 1994 |
| Days to Decision | 94 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DXK — Echocardiograph |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2330 |