Submission Details
| 510(k) Number | K990339 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 03, 1999 |
| Decision Date | February 18, 1999 |
| Days to Decision | 15 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
Cleared
Traditional
SONOS 5500 IMAGING SYSTEM M2424A VERSION B.O
Feb 1999
Decision
15d
Days
Class 2
Risk
About This 510(k) Submission
K990339 is an FDA 510(k) clearance for the SONOS 5500 IMAGING SYSTEM M2424A VERSION B.O, a System, Imaging, Pulsed Doppler, Ultrasonic (Class II — Special Controls, product code IYN), submitted by Hewlett-Packard Co. (Andover, US). The FDA issued a Cleared decision on February 18, 1999, 15 days after receiving the submission on February 3, 1999. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1550.
Device Classification
| Product Code | IYN — System, Imaging, Pulsed Doppler, Ultrasonic |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 892.1550 |
Manufacturer
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