Name: Predicase
Price: 199 USD

K-number	K234153
Device name	EdgeLife Handheld Wireless Ultrasound System (E8200); EdgeLife Handheld Wireless Ultrasound System (E8220)
Applicant	Edgelife Technologies, LLC
Product code	IYN
Device class	Class II
Decision date	Sep 18, 2024
Decision	Substantially Equivalent
Regulation	892.1550

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Source

View the full FDA submission: accessdata.fda.gov

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EdgeLife Handheld Wireless Ultrasound System (E8200); EdgeLife Handheld Wireless Ultrasound System (E8220)

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