Vu-Path Ultrasound System

System, Imaging, Pulsed Doppler, Ultrasonic

Crystalline Medical

The following data is part of a premarket notification filed by Crystalline Medical with the FDA for Vu-path Ultrasound System.

Pre-market Notification Details

Device IDK203657
510k NumberK203657
Device Name:Vu-Path Ultrasound System
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant Crystalline Medical 48890 Milmont Drive Suite 106D Fremont,  CA  94538
ContactIvan Ma
CorrespondentPrithul Bom
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedYes
Combination ProductNo
Date Received2020-12-15
Decision Date2021-06-25

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