K011265 is an FDA 510(k) clearance for the ULTRASOUND TRANSDUCER COVER. This device is classified as a Transducer, Ultrasonic, Diagnostic (Class II - Special Controls, product code ITX).
Submitted by Advance Medical Designs, Inc. (Marietta, US). The FDA issued a Cleared decision on October 30, 2001, 188 days after receiving the submission on April 25, 2001.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1570.
| 510(k) Number | K011265 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 25, 2001 |
| Decision Date | October 30, 2001 |
| Days to Decision | 188 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Statement |
| Product Code | ITX — Transducer, Ultrasonic, Diagnostic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1570 |