510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K032278Substantially Equivalent

Ambu Neuroline Single Patient Eeg/ep Cup Electrode

Ambu, Inc., Linthicum MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K032278 is the FDA 510(k) clearance record for AMBU NEUROLINE SINGLE PATIENT EEG/EP CUP ELECTRODE, a class II device, cleared for Ambu, Inc. on under FDA product code GXY (Electrode, Cutaneous). FDA records list 22 510(k) clearances for Ambu, Inc., from to . As of , FDA records show no recalls naming K032278.

Clearance record

Decision date
Received
(225 days to decision)
Product code
GXY Electrode, Cutaneous
Regulation
21 CFR 882.1320
Device class
Class II
Review panel
Neurology
Applicant
Ambu, Inc. 611 N. Hammonds Ferry Rd., Linthicum MD
510(k) summary
Statement
Third party review
No

Clearances, product code GXY

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