Cleared Traditional

K915138 - GE SONOCHROME
(FDA 510(k) Clearance)

K915138 · GE Medical Systems · Radiology
Oct 1992
Decision
342d
Days
Class 2
Risk

K915138 is an FDA 510(k) clearance for the GE SONOCHROME, a Monitor, Fetal Doppler Ultrasound (Class II — Special Controls, product code MAA), submitted by GE Medical Systems (Waukesha, US). The FDA issued a Cleared decision on October 20, 1992, 342 days after receiving the submission on November 13, 1991. This device falls under the Radiology review panel. Regulated under 21 CFR 884.2660.

Submission Details

510(k) Number K915138 FDA.gov
FDA Decision Cleared SESE
Date Received November 13, 1991
Decision Date October 20, 1992
Days to Decision 342 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code MAA — Monitor, Fetal Doppler Ultrasound
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.2660