K870916 is an FDA 510(k) clearance for the SSD-633 PHASED ARRAY SECTOR/LINEAR ULTRASOUND SYS.. This device is classified as a Transducer, Ultrasonic (Class II - Special Controls, product code JOP).
Submitted by Ge Medical Systems Information Technologies (Wallingford, US). The FDA issued a Cleared decision on July 21, 1987, 137 days after receiving the submission on March 6, 1987.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2880.
| 510(k) Number | K870916 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 06, 1987 |
| Decision Date | July 21, 1987 |
| Days to Decision | 137 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | - |
| Product Code | JOP - Transducer, Ultrasonic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2880 |