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

Stimulator, Mechanical, Evoked Response

21 CFR 882.1880 / Neurology
FDA source (opens on fda.gov)

GZP is the FDA product code for Stimulator, Mechanical, Evoked Response, a class II device type, regulated under 21 CFR 882.1880. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
GZP
Device name
Stimulator, Mechanical, Evoked Response
Regulation
21 CFR 882.1880
Device class
Class II
Review panel
Neurology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
2
Ingested recalls
0

Clearances, product code GZP

By decision year
2 clearances under product code GZP with a decision year between 1991 and 2019, 1991 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code GZP by decision year
YearClearances
19911
20191

Applicants with the most clearances

Product code GZP
Applicants holding the most 510(k) clearances under product code GZP
ApplicantClearances
Biomagnetic Technologies, Inc.1
Blinktbi, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code