ECHOHEART TRANSVAGINAL DOPPLER PROBE— 510(k) K060410

Name: FDA 510(k) clearance K060410
Creator: U.S. Food and Drug Administration
Published: 2006-04-10

Substantially Equivalent

Summit Doppler Systems, Inc.

FDA 510(k) clearance K060410 for ECHOHEART TRANSVAGINAL DOPPLER PROBE, Substantially Equivalent on 2006-04-10. Applicant: Summit Doppler Systems, Inc.. Device class: 2.

Clearance details

Applicant: Summit Doppler Systems, Inc.
Product code: Code HEK
Device class: Class 2
Regulation: 21 CFR 884.2660
Advisory panel: Obstetrics/Gynecology
Date received: 2006-02-16
Decision date: 2006-04-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Golden, CO, 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.