K-number	K231764
Device name	Ultrasound System 1300
Applicant	Bk Medical Aps
Product code	IYN
Device class	Class II
Decision date	Oct 23, 2023
Decision	Substantially Equivalent
Regulation	892.1550

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Source

View the full FDA submission: accessdata.fda.gov

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Ultrasound System 1300

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