K-number	K211513
Device name	sam X1 Long Duration Ultrasound Device
Applicant	ZetrOZ Systems, LLC
Product code	PFW
Device class	Class II
Decision date	Aug 18, 2021
Decision	Substantially Equivalent
Regulation	890.5300

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Source

View the full FDA submission: accessdata.fda.gov

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sam X1 Long Duration Ultrasound Device

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