510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K915138Substantially Equivalent

Ge Sonochrome

GE Healthcare, Waukesha WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K915138 is the FDA 510(k) clearance record for GE SONOCHROME, a class II device, cleared for GE Medical Systems on under FDA product code MAA (Monitor, Fetal Doppler Ultrasound). FDA records list 888 510(k) clearances for GE HEALTHCARE, from to . As of , FDA records show no recalls naming K915138.

Clearance record

Decision date
Received
(342 days to decision)
Product code
MAA Monitor, Fetal Doppler Ultrasound
Regulation
21 CFR 884.2660
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
GE Medical Systems 3000 N. Grandview Blvd., Waukesha WI
510(k) summary
Summary
Third party review
No

Clearances, product code MAA

Trailing 12 months

FDA records hold no clearances under product code MAA in the trailing twelve months.

FDA records show no clearances under product code MAA in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MAA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260