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

Tester, Electrode/Lead, Electroencephalograph

21 CFR 882.1410 / Neurology
FDA source (opens on fda.gov)

GYA is the FDA product code for Tester, Electrode/Lead, Electroencephalograph, a class I device type, regulated under 21 CFR 882.1410. As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
GYA
Device name
Tester, Electrode/Lead, Electroencephalograph
Regulation
21 CFR 882.1410
Device class
Class I
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
5
Ingested recalls
0

Clearances, product code GYA

By decision year
5 clearances under product code GYA with a decision year between 1978 and 1988, 1978 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code GYA by decision year
YearClearances
19781
19821
19831
19861
19881

Applicants with the most clearances

Product code GYA
Applicants holding the most 510(k) clearances under product code GYA
ApplicantClearances
Cadwell Laboratories, Inc.1
E-Z Instruments Co.1
General Devices1
Life-Tech Instruments, Inc.1
World Precision Instruments, LLC1

Companies listing this code with FDA

Companies whose registered establishments list this code