OMIKRON PACEMAKER 837 UNIPOLAR & 838 BIPOLAR— 510(k) K844277

Substantially Equivalent

Omikron Scientific, Ltd.

FDA 510(k) clearance K844277 for OMIKRON PACEMAKER 837 UNIPOLAR & 838 BIPOLAR, Substantially Equivalent on 1985-02-15. Applicant: Omikron Scientific, Ltd..

Clearance details

Applicant: Omikron Scientific, Ltd.
Product code: Code DXG
Advisory panel: Cardiovascular
Date received: 1984-11-05
Decision date: 1985-02-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Israel, IL

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