SOUNMED COLOPOSCOPE COLPO-99/99PLUS— 510(k) K070845

Name: FDA 510(k) clearance K070845
Creator: U.S. Food and Drug Administration
Published: 2007-10-12

Substantially Equivalent

Sounmed, Inc.

FDA 510(k) clearance K070845 for SOUNMED COLOPOSCOPE COLPO-99/99PLUS, Substantially Equivalent on 2007-10-12. Applicant: Sounmed, Inc.. Device class: 2.

Clearance details

Applicant: Sounmed, Inc.
Product code: Code HEX
Device class: Class 2
Regulation: 21 CFR 884.1630
Advisory panel: Obstetrics/Gynecology
Date received: 2007-03-27
Decision date: 2007-10-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

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