510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K032935Substantially Equivalent

Epi-Scan, Model P 100

Edx Epi-Scan, Inc., Irvine CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K032935 is the FDA 510(k) clearance record for EPI-SCAN, MODEL P 100, a class II device, cleared for Edx Epi-Scan, Inc. on under FDA product code GZO (Device, Galvanic Skin Response Measurement). FDA records list one 510(k) clearance for Edx Epi-Scan, Inc. As of , FDA records show no recalls naming K032935.

Clearance record

Decision date
Received
(59 days to decision)
Product code
GZO Device, Galvanic Skin Response Measurement
Regulation
21 CFR 882.1540
Device class
Class II
Review panel
Neurology
Applicant
Edx Epi-Scan, Inc. 3722 Ave. Sausalito, Irvine CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GZO

Trailing 12 months

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

FDA records show no clearances under product code GZO in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GZO, 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