RSX 1000

System, X-ray, Extraoral Source, Digital

Rolence Enterprise Inc.

The following data is part of a premarket notification filed by Rolence Enterprise Inc. with the FDA for Rsx 1000.

Pre-market Notification Details

Device IDK202369
510k NumberK202369
Device Name:RSX 1000
ClassificationSystem, X-ray, Extraoral Source, Digital
Applicant Rolence Enterprise Inc. 18-3 Lane 231 Pu Chung Rd., Chungli Taoyuan,  TW 32083
ContactBen Chang
CorrespondentBen Chang
Rolence Enterprise Inc. 18-3 Lane 231 Pu Chung Rd., Chungli Taoyuan,  TW 32083
Product CodeMUH  
CFR Regulation Number872.1800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-19
Decision Date2021-09-15

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