MCPULSE— 510(k) K023238

Substantially Equivalent

Meridian Co., Ltd.

FDA 510(k) clearance K023238 for MCPULSE, Substantially Equivalent on 2003-02-19. Applicant: Meridian Co., Ltd.. Device class: 2.

Clearance details

Applicant: Meridian Co., Ltd.
Product code: Code JOM
Device class: Class 2
Regulation: 21 CFR 870.2780
Advisory panel: Cardiovascular
Date received: 2002-09-27
Decision date: 2003-02-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Deer Field, IL, US

Download summary PDF View on FDA.gov ↗

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