FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

THYMAPAD

K Number: K882809 · Decision Sep 27, 1988
Classifications
1
FEI Numbers
243
Registration Numbers
243
Same Product Code
436
Applicant Total
7
Review Days
82

Research this 510(k) in seconds

The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

Free to try · every answer cites its records

Basic Information

Device Name
THYMAPAD
K Number
K882809
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
882.1320
Medical Specialty
Neurology
Decision
Substantially Equivalent
Applicant
Somatics, Inc.
Date Received
July 7, 1988
Decision Date
September 27, 1988
Product Code
GXY
Advisory Committee
Neurology
Review Advisory Committee
NE
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
GXY Electrode, Cutaneous

Similar 510(k) Clearances

Other 510(k) clearances with the same product code (GXY), ordered by most recent decision date.

View all

Other Clearances by Somatics, Inc.

K Number Device Name
K992269 VENTIL-A ORAL PROTECTOR
K945120 THYMATRON 2000 ELECTROCONVULSIVE SYSTEM
K890711 DUAL GRAPH (TM) RECORDER-MONITOR
K890710 DISPOSABLE EEG/EKG ELECTRODE, CAT. #EEDS
K864181 SOMATICS MOUTH GUARD (BITE BLOCK)
K843923 THYMATRON