Name: Predicase
Price: 199 USD

K-number	K903816
Device name	URINE METER FOLEY TRAY WITH TEMPERATURE SENSOR
Applicant	Respiratory Support Products, Inc.
Product code	EZK
Device class	Class II
Decision date	Oct 31, 1990
Decision	Substantially Equivalent — Kit Device
Regulation	876.5980

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Source

View the full FDA submission: accessdata.fda.gov

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URINE METER FOLEY TRAY WITH TEMPERATURE SENSOR

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