SITE-RITE VISION ULTRASOUND SYSTEM
FDA 510(k) clearance K100402 · decided 2010-03-05
Clearance details
- K-number
- K100402
- Device name
- SITE-RITE VISION ULTRASOUND SYSTEM
- Applicant
- Bard Access Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-02-16
- Decision date
- 2010-03-05
- Days to decision
- 17 days
- Clearance type
- Traditional
- Product code
- IYN
- Device class
- 2
- Regulation number
- 892.1550
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Salt Lake Ciy,, UT, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Site Rite Vision Ultrasound System, REF 9770032, Bard Access Systems, Inc. Intended for di recall (Z-2782-2011) | Bard Access Systems | 2011-07-11 |