Submission Details
| 510(k) Number | K920882 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 26, 1992 |
| Decision Date | March 26, 1993 |
| Days to Decision | 394 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Statement |
K920882 is an FDA 510(k) clearance for the ACUSON V714 TRANSDUCER, a Transducer, Ultrasonic, Diagnostic (Class II — Special Controls, product code ITX), submitted by Acuson Corp. (Mountain View, US). The FDA issued a Cleared decision on March 26, 1993, 394 days after receiving the submission on February 26, 1992. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1570.
| 510(k) Number | K920882 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 26, 1992 |
| Decision Date | March 26, 1993 |
| Days to Decision | 394 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 |