HealthCCSng

System, X-ray, Tomography, Computed

Zebra Medical Vision Ltd.

The following data is part of a premarket notification filed by Zebra Medical Vision Ltd. with the FDA for Healthccsng.

Pre-market Notification Details

Device IDK210085
510k NumberK210085
Device Name:HealthCCSng
ClassificationSystem, X-ray, Tomography, Computed
Applicant Zebra Medical Vision Ltd. Shefayim Commercial Center, PO Box 25 Shefayim,  IL 6099000
ContactShlomit Cymbalista
CorrespondentShlomit Cymbalista
Zebra Medical Vision Ltd. Shefayim Commercial Center, PO Box 25 Shefayim,  IL 6099000
Product CodeJAK  
CFR Regulation Number892.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-01-13
Decision Date2021-09-15

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.