Submission Details
| 510(k) Number | K100402 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 16, 2010 |
| Decision Date | March 05, 2010 |
| Days to Decision | 17 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
Cleared
Traditional
K100402: SITE-RITE VISION ULTRASOUND SYSTEM
Mar 2010
Decision
17d
Days
Class 2
Risk
About This 510(k) Submission
K100402 is an FDA 510(k) clearance for the SITE-RITE VISION ULTRASOUND SYSTEM, a System, Imaging, Pulsed Doppler, Ultrasonic (Class II — Special Controls, product code IYN), submitted by Bard Access Systems, Inc. (Salt Lake Ciy,, US). The FDA issued a Cleared decision on March 5, 2010, 17 days after receiving the submission on February 16, 2010. 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 |
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