The following data is part of a premarket notification filed by C.r. Bard, Inc with the FDA for Site-rite 6 Ultrasound System With Pinpoint Gt Technology.
Device ID | K142443 |
510k Number | K142443 |
Device Name: | Site-Rite 6 Ultrasound System With Pinpoint GT Technology |
Classification | System, Imaging, Pulsed Echo, 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 | IYO |
CFR Regulation Number | 892.1560 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-09-02 |
Decision Date | 2014-10-30 |
Summary: | summary |