Klarity Bolus

Accelerator, Linear, Medical

Klarity Medical & Equipment (GZ) Co., Ltd.

The following data is part of a premarket notification filed by Klarity Medical & Equipment (gz) Co., Ltd. with the FDA for Klarity Bolus.

Pre-market Notification Details

Device IDK202747
510k NumberK202747
Device Name:Klarity Bolus
ClassificationAccelerator, Linear, Medical
Applicant Klarity Medical & Equipment (GZ) Co., Ltd. No. 14 3rd St., Shawan GETDD Guangzhou,  CN 510730
ContactLucy Li
CorrespondentPeter Larson
Klarity Medical Products, LLC 600 Industrial Parkway Heath,  OH  43056
Product CodeIYE  
CFR Regulation Number892.5050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-21
Decision Date2021-05-14

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