K881185 is an FDA 510(k) clearance for the ANNULAR ARRAY PROBES FOR ARTIS 3200 DIAG. ULTRA.. This device is classified as a Imager, Ultrasonic Obstetric-gynecologic (Class II - Special Controls, product code HEM).
Submitted by Philips Medical Systems (Cleveland), Inc. (Highland Heights, US). The FDA issued a Cleared decision on June 1, 1988, 72 days after receiving the submission on March 21, 1988.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.2225.
| 510(k) Number | K881185 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 21, 1988 |
| Decision Date | June 01, 1988 |
| Days to Decision | 72 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | — |
| Product Code | HEM — Imager, Ultrasonic Obstetric-gynecologic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.2225 |