ECLERIS MICROSTAR COLPOSCOPE— 510(k) K100595

Substantially Equivalent

Ecleris USA

FDA 510(k) clearance K100595 for ECLERIS MICROSTAR COLPOSCOPE, Substantially Equivalent on 2010-07-09. Applicant: Ecleris USA. Device class: 2.

Clearance details

Applicant: Ecleris USA
Product code: Code HEX
Device class: Class 2
Regulation: 21 CFR 884.1630
Advisory panel: Obstetrics/Gynecology
Date received: 2010-03-02
Decision date: 2010-07-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, 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.