K880217 is an FDA 510(k) clearance for the SSD-870 CARDIO VASCULAR PHASED ARRAY SECTOR SCANN.. This device is classified as a Echocardiograph (Class II - Special Controls, product code DXK).
Submitted by Ge Medical Systems Information Technologies (Wallingford, US). The FDA issued a Cleared decision on April 25, 1988, 96 days after receiving the submission on January 20, 1988.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2330.
| 510(k) Number | K880217 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 20, 1988 |
| Decision Date | April 25, 1988 |
| Days to Decision | 96 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | - |
| Product Code | DXK - Echocardiograph |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2330 |