FLEXI-STAT SP02 EAR SENSOR— 510(k) K042675

Substantially Equivalent

Elekon Industries U.S.A., Inc.

FDA 510(k) clearance K042675 for FLEXI-STAT SP02 EAR SENSOR, Substantially Equivalent on 2004-12-06. Applicant: Elekon Industries U.S.A., Inc..

Clearance details

Applicant: Elekon Industries U.S.A., Inc.
Product code: Code DPZ
Advisory panel: Cardiovascular
Date received: 2004-09-29
Decision date: 2004-12-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plano, TX, US

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