K-number	K851245
Device name	ADDITION OF 50% OXYGEN TO APPLINC SAVING BREATH HY
Applicant	Applinc
Product code	BZE
Device class	Class II
Decision date	May 15, 1985
Decision	Substantially Equivalent
Regulation	868.5270

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View the full FDA submission: accessdata.fda.gov

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ADDITION OF 50% OXYGEN TO APPLINC SAVING BREATH HY

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