Name: Predicase
Price: 199 USD

K-number	K213282
Device name	ERI Handheld Dental X-ray System (Model AG100)
Applicant	Energy Resources International Co., Ltd. Hsinchu Branch
Product code	EHD
Device class	Class II
Decision date	Apr 4, 2022
Decision	Substantially Equivalent
Regulation	872.1800

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Source

View the full FDA submission: accessdata.fda.gov

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ERI Handheld Dental X-ray System (Model AG100)

Everything you need for a 510(k) submission. Nothing you don't.