The following data is part of a premarket notification filed by Bard Access Systems, Inc. with the FDA for Site-rite Vision Ultrasound System.
| Device ID | K100402 |
| 510k Number | K100402 |
| Device Name: | SITE-RITE VISION ULTRASOUND SYSTEM |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | BARD ACCESS SYSTEMS, INC. 605 NORTH 5600 WEST Salt Lake City, UT 84116 |
| Contact | Kimberly Geisler |
| Correspondent | Robert Mosenkin CITECH 5200 BUTLER PIKE Plymouth Meeting, PA 19462 -1298 |
| Product Code | IYN |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| Subsequent Product Code | LLZ |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2010-02-16 |
| Decision Date | 2010-03-05 |
| Summary: | summary |