Solas OR

Cabinet, X-ray System

Cirdan Imaging Ltd

The following data is part of a premarket notification filed by Cirdan Imaging Ltd with the FDA for Solas Or.

Pre-market Notification Details

Device IDK213691
510k NumberK213691
Device Name:Solas OR
ClassificationCabinet, X-ray System
Applicant Cirdan Imaging Ltd The Green, Tullynacross Rd, Lambeg Lisburn,  GB Bt27 5sr
ContactPaul Matthews
CorrespondentPrithul Bom
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeMWP  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2021-11-23
Decision Date2021-12-22

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