510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K082540Substantially Equivalent

Ge Entropy Sensor

GE Healthcare, Needham MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K082540 is the FDA 510(k) clearance record for GE ENTROPY SENSOR, a class II device, cleared for GE Healthcare on under FDA product code GXY (Electrode, Cutaneous). FDA records list 888 510(k) clearances for GE Healthcare, from to . As of , FDA records show no recalls naming K082540.

Clearance record

Decision date
Received
(87 days to decision)
Product code
GXY Electrode, Cutaneous
Regulation
21 CFR 882.1320
Device class
Class II
Review panel
Neurology
Applicant
GE Healthcare 86 Pilgrim Rd., Needham MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GXY

Trailing 12 months
12 clearances under product code GXY in the twelve months to November 2026, May 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code GXY, trailing twelve months
MonthClearances
December 20250
January 20260
February 20261
March 20261
April 20262
May 20263
June 20262
July 20261
August 20261
September 20260
October 20261
November 20260