MAX PULSE SYSTEM— 510(k) K110374

Substantially Equivalent

Medicore Co., Ltd.

FDA 510(k) clearance K110374 for MAX PULSE SYSTEM, Substantially Equivalent on 2011-06-13. Applicant: Medicore Co., Ltd.. Device class: 2.

Clearance details

Applicant: Medicore Co., Ltd.
Product code: Code JOM
Device class: Class 2
Regulation: 21 CFR 870.2780
Advisory panel: Cardiovascular
Date received: 2011-02-09
Decision date: 2011-06-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul, KR

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.