K-number	K233210
Device name	sam CS Long Duration Ultrasound Device
Applicant	ZetrOZ Systems, LLC
Product code	PFW
Device class	Class II
Decision date	Oct 25, 2023
Decision	Substantially Equivalent
Regulation	890.5300

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Source

View the full FDA submission: accessdata.fda.gov

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sam CS Long Duration Ultrasound Device

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