K851895 is an FDA 510(k) clearance for the POLYGEL ULTRASOUND GEL. This device is classified as a System, Imaging, Pulsed Echo, Ultrasonic (Class II - Special Controls, product code IYO).
Submitted by Parker Laboratories, Inc. (Orange, US). The FDA issued a Cleared decision on September 27, 1985, 150 days after receiving the submission on April 30, 1985.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1560.
| 510(k) Number | K851895 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 30, 1985 |
| Decision Date | September 27, 1985 |
| Days to Decision | 150 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 |