510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K920352Substantially Equivalent

Bio-Detek EEG Electrode

ZOLL Medical Corporation, Attleboro MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K920352 is the FDA 510(k) clearance record for BIO-DETEK EEG ELECTRODE, a class II device, cleared for Bio-Detek, Inc. on under FDA product code GXZ (Electrode, Needle). FDA records list 149 510(k) clearances for ZOLL MEDICAL CORPORATION, from to . As of , FDA records show no recalls naming K920352.

Clearance record

Decision date
Received
(200 days to decision)
Product code
GXZ Electrode, Needle
Regulation
21 CFR 882.1350
Device class
Class II
Review panel
Neurology
Applicant
Bio-Detek, Inc. 453 S. Main St.,, Attleboro MA
510(k) summary
Statement
Third party review
No

Clearances, product code GXZ

Trailing 12 months

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

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