K-number	K894267
Device name	OPUS MODELS 4033 AND 4034
Applicant	Ela Medical, Inc.
Product code	DXY
Device class	Class III
Decision date	Sep 20, 1989
Decision	Substantially Equivalent
Regulation	870.3610

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View the full FDA submission: accessdata.fda.gov

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OPUS MODELS 4033 AND 4034

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