K864980 is an FDA 510(k) clearance for the 3MHZ ANNULAR ARRAY. This device is classified as a Transducer, Ultrasonic (Class II - Special Controls, product code JOP).
Submitted by Philips Ultrasound, Inc. (Santa Ana, US). The FDA issued a Cleared decision on May 11, 1987, 140 days after receiving the submission on December 22, 1986.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2880.
| 510(k) Number | K864980 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 22, 1986 |
| Decision Date | May 11, 1987 |
| Days to Decision | 140 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 |