K-number	K882913
Device name	DTR ANALYZER
Applicant	Abbott Laboratories
Product code	JJE
Device class	Class I
Decision date	Aug 30, 1988
Decision	Substantially Equivalent
Regulation	862.2160

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Source

View the full FDA submission: accessdata.fda.gov

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DTR ANALYZER

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