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

Device, Galvanic Skin Response Measurement

21 CFR 882.1540 / Neurology
FDA source (opens on fda.gov)

GZO is the FDA product code for Device, Galvanic Skin Response Measurement, a class II device type, regulated under 21 CFR 882.1540. As of , FDA records hold 26 510(k) clearances under this code, the most recent dated , and 3 recalls.

Classification record

Product code
GZO
Device name
Device, Galvanic Skin Response Measurement
Regulation
21 CFR 882.1540
Device class
Class II
Review panel
Neurology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
26
Ingested recalls
3

Clearances, product code GZO

By decision year
26 clearances under product code GZO with a decision year between 1984 and 2015, 2002 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code GZO by decision year
YearClearances
19841
19881
19891
19951
19971
19992
20002
20012
20025
20032
20061
20102
20111
20131
20141
20152

Applicants with the most clearances

Product code GZO
Applicants holding the most 510(k) clearances under product code GZO
ApplicantClearances
LD Technology LLC3
Meridian AG3
Vibrant Health3
Biomeridian, Int.2
Impeto Medical2
Bio-Scan, Inc.1
Edx Epi-Scan, Inc.1
Engineering Dynamics Corp.1
Epi-Scan Corp.1
Galloway Technologies, LLC1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 26 companies shown, in name order