K897151 is an FDA 510(k) clearance for the ACUSON V328 AND C5432 TRANSDUCERS. This device is classified as a Transport Systems, Anaerobic (Class I - General Controls, product code JTX).
Submitted by Acuson Corp. (Mountain View, US). The FDA issued a Cleared decision on July 3, 1990, 189 days after receiving the submission on December 26, 1989.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2900.
| 510(k) Number | K897151 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 26, 1989 |
| Decision Date | July 03, 1990 |
| Days to Decision | 189 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | JTX — Transport Systems, Anaerobic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2900 |