K-number	K822873
Device name	DEVETHERM
Applicant	Eko Scann AB
Product code	DQB
Device class	Class II
Decision date	Mar 24, 1983
Decision	Substantially Equivalent
Regulation	870.2750

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View the full FDA submission: accessdata.fda.gov

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DEVETHERM

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