Pocket Colposcope System— 510(k) K181034

Name: FDA 510(k) clearance K181034
Creator: U.S. Food and Drug Administration
Published: 2018-09-21

Substantially Equivalent

Hadleigh Health Technologies, LLC

FDA 510(k) clearance K181034 for Pocket Colposcope System, Substantially Equivalent on 2018-09-21. Applicant: Hadleigh Health Technologies, LLC. Device class: 2.

Clearance details

Applicant: Hadleigh Health Technologies, LLC
Product code: Code HEX
Device class: Class 2
Regulation: 21 CFR 884.1630
Advisory panel: Obstetrics/Gynecology
Date received: 2018-04-18
Decision date: 2018-09-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Rafael, CA, US

Download summary PDF View on FDA.gov ↗

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