The following data is part of a premarket notification filed by Bard Access Systems, Inc. with the FDA for Site Rite Prevue Ultrasound System And Pinpoint Needle Guide.
| Device ID | K120882 |
| 510k Number | K120882 |
| Device Name: | SITE RITE PREVUE ULTRASOUND SYSTEM AND PINPOINT NEEDLE GUIDE |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | BARD ACCESS SYSTEMS, INC. 605 NORTH 5600 WEST Salt Lake City, UT 84116 |
| Contact | Henry Boland |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2012-03-23 |
| Decision Date | 2012-05-30 |
| Summary: | summary |