K900881 is an FDA 510(k) clearance for the OR-340 INTRAOPERATIVE ULTRASOUND SYSTEM. This device is classified as a System, Imaging, Pulsed Echo, Ultrasonic (Class II - Special Controls, product code IYO).
Submitted by Codman & Shurtleff, Inc. (Attleboro, US). The FDA issued a Cleared decision on September 25, 1990, 211 days after receiving the submission on February 26, 1990.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1560.
| 510(k) Number | K900881 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 26, 1990 |
| Decision Date | September 25, 1990 |
| Days to Decision | 211 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | - |
| Product Code | IYO - System, Imaging, Pulsed Echo, Ultrasonic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1560 |