Cleared Traditional

ECHOHEART TRANSVAGINAL DOPPLER PROBE

K060410 · Summit Doppler Systems, Inc. · Radiology

Apr 2006

Decision

53d

Days

Class 2

Risk

About This 510(k) Submission

K060410 is an FDA 510(k) clearance for the ECHOHEART TRANSVAGINAL DOPPLER PROBE, a Monitor, Heart Sound, Fetal, Ultrasonic (Class II — Special Controls, product code HEK), submitted by Summit Doppler Systems, Inc. (Golden, US). The FDA issued a Cleared decision on April 10, 2006, 53 days after receiving the submission on February 16, 2006. This device falls under the Radiology review panel. Regulated under 21 CFR 884.2660.

Submission Details

510(k) Number	K060410 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 16, 2006
Decision Date	April 10, 2006
Days to Decision	53 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF