The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Site-rite Vision Ii Ultrasound System.
Device ID | K132942 |
510k Number | K132942 |
Device Name: | SITE-RITE VISION II ULTRASOUND SYSTEM |
Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
Applicant | C.R. BARD, INC. 605 NORTH 5600 WEST Salt Lake City, UT 84116 |
Contact | Kerrie Hamblin |
Correspondent | Kerrie Hamblin C.R. BARD, INC. 605 NORTH 5600 WEST Salt Lake City, UT 84116 |
Product Code | IYN |
CFR Regulation Number | 892.1550 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-09-19 |
Decision Date | 2013-10-17 |
Summary: | summary |