Submission Details
| 510(k) Number | K021497 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 09, 2002 |
| Decision Date | July 09, 2002 |
| Days to Decision | 61 days |
| Submission Type | Special |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
K021497 is an FDA 510(k) clearance for the CYPRESS ULTRASOUND SYSTEM, a System, Imaging, Pulsed Doppler, Ultrasonic (Class II — Special Controls, product code IYN), submitted by Acuson Corp. (Mountain View, US). The FDA issued a Cleared decision on July 9, 2002, 61 days after receiving the submission on May 9, 2002. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1550.
| 510(k) Number | K021497 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 09, 2002 |
| Decision Date | July 09, 2002 |
| Days to Decision | 61 days |
| Submission Type | Special |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IYN — System, Imaging, Pulsed Doppler, Ultrasonic |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 892.1550 |