C. NET 2100— 510(k) K010396

Substantially Equivalent

Cardionetics, Ltd.

FDA 510(k) clearance K010396 for C. NET 2100, Substantially Equivalent on 2001-10-04. Applicant: Cardionetics, Ltd.. Device class: 2.

Clearance details

Applicant: Cardionetics, Ltd.
Product code: Code MLO
Device class: Class 2
Regulation: 21 CFR 870.2800
Advisory panel: Cardiovascular
Date received: 2001-02-09
Decision date: 2001-10-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waltham, MA, US

Download summary PDF View on FDA.gov ↗

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