Cleared Traditional

DOPPLER (UTD-5 & UTD-6)

K771211 · Terumo America, Inc. · Obstetrics & Gynecology
Jul 1977
Decision
9d
Days
Class 2
Risk

About This 510(k) Submission

K771211 is an FDA 510(k) clearance for the DOPPLER (UTD-5 & UTD-6), a Monitor, Heart Sound, Fetal, Ultrasonic (Class II — Special Controls, product code HEK), submitted by Terumo America, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 14, 1977, 9 days after receiving the submission on July 5, 1977. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.2660.

Submission Details

510(k) Number K771211 FDA.gov
FDA Decision Cleared SESE
Date Received July 05, 1977
Decision Date July 14, 1977
Days to Decision 9 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary —

Device Classification

Product Code HEK — Monitor, Heart Sound, Fetal, Ultrasonic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.2660