K871400 is an FDA 510(k) clearance for the SSD-650 LINEAR, CONVEX SECTOR, ULTRASOUND SCANNING. 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 July 24, 1987, 107 days after receiving the submission on April 8, 1987.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2330.
| 510(k) Number | K871400 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 08, 1987 |
| Decision Date | July 24, 1987 |
| Days to Decision | 107 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 |