K960143 is an FDA 510(k) clearance for the G.E. STERILE DIGITAL ANGIOGRAPHIC TRAY. This device is classified as a Instruments, Surgical, Cardiovascular (Class I - General Controls, product code DWS).
Submitted by GE Medical Systems (Palm Harbor, US). The FDA issued a Cleared decision on April 9, 1996, 84 days after receiving the submission on January 16, 1996.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4500.
| 510(k) Number | K960143 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | January 16, 1996 |
| Decision Date | April 09, 1996 |
| Days to Decision | 84 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| Product Code | DWS - Instruments, Surgical, Cardiovascular |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 870.4500 |