510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
GWSClass I

Analyzer, Spectrum, Electroencephalogram Signal

21 CFR 882.1420 / Neurology
FDA source (opens on fda.gov)

GWS is the FDA product code for Analyzer, Spectrum, Electroencephalogram Signal, a class I device type, regulated under 21 CFR 882.1420. As of , FDA records hold 15 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
GWS
Device name
Analyzer, Spectrum, Electroencephalogram Signal
Regulation
21 CFR 882.1420
Device class
Class I
Review panel
Neurology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
15
Ingested recalls
0

Clearances, product code GWS

By decision year
15 clearances under product code GWS with a decision year between 1980 and 1998, 1986 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code GWS by decision year
YearClearances
19802
19811
19841
19852
19863
19872
19901
19911
19931
19981

Applicants with the most clearances

Product code GWS
Applicants holding the most 510(k) clearances under product code GWS
ApplicantClearances
Cns, Inc.3
Neuroscience, Inc.2
Bik Foundation, Inc.1
Bio-Scan, Inc.1
Dade Medical, Inc.1
Grass-Telefactor Product Group1
Neurometrics1
Nicolet Instrument Corp.1
Nihon Kohden America Inc1
Persyst Development LLC1

Companies listing this code with FDA

Companies whose registered establishments list this code