K-number	K233937
Device name	OW100S
Applicant	Softwave/Trt, LLC
Product code	PZL
Device class	Class II
Decision date	Jul 9, 2024
Decision	Substantially Equivalent
Regulation	878.4685

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Source

View the full FDA submission: accessdata.fda.gov

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OW100S

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