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

Conditioner, Signal, Physiological

21 CFR 882.1845 / Neurology
FDA source (opens on fda.gov)

GWK is the FDA product code for Conditioner, Signal, Physiological, a class II device type, regulated under 21 CFR 882.1845. As of , FDA records hold 23 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
GWK
Device name
Conditioner, Signal, Physiological
Regulation
21 CFR 882.1845
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
23
Ingested recalls
0

Clearances, product code GWK

By decision year
23 clearances under product code GWK with a decision year between 1977 and 2006, 1977 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code GWK by decision year
YearClearances
19772
19782
19802
19811
19832
19842
19851
19861
19872
19881
19901
19912
19991
20051
20062

Applicants with the most clearances

Product code GWK
Applicants holding the most 510(k) clearances under product code GWK
ApplicantClearances
Respironics, Inc.3
Bio-Logic Systems Corp.2
Neurodiagnostics, Inc.2
Nicolet Biomedical Instruments2
Nihon Kohden America Inc2
Astro-Med, Inc.1
Axonics, Inc.1
Bio-Feedback Systems, Inc.1
Elmed, Inc.1
Grass Instrument Co.1

Companies listing this code with FDA

Companies whose registered establishments list this code