K920353 is an FDA 510(k) clearance for the ULTRACELL INSTRUMENT WIPE, a Monitor, Blood-flow, Ultrasonic (Class II — Special Controls, product code HEP), submitted by Ultracell Medical Technologies, Inc. (North Stonington, US). The FDA issued a Cleared decision on September 15, 1992, 232 days after receiving the submission on January 27, 1992. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.2660.
| 510(k) Number | K920353 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 27, 1992 |
| Decision Date | September 15, 1992 |
| Days to Decision | 232 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Statement |
| Product Code | HEP — Monitor, Blood-flow, Ultrasonic |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.2660 |