K-number	K896738
Device name	TYPE 9293 INTERFACE PULSEOX
Applicant	S & W Medico Teknik
Product code	DQA
Device class	Class II
Decision date	Aug 14, 1990
Decision	Substantially Equivalent
Regulation	870.2700

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View the full FDA submission: accessdata.fda.gov

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TYPE 9293 INTERFACE PULSEOX

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