TRANSCRANIAL ELECTROTHERAPY STIMULATOR-A, MODEL TESA-1

Stimulator, Cranial Electrotherapy

KALACO SCIENTIFIC, INC.

The following data is part of a premarket notification filed by Kalaco Scientific, Inc. with the FDA for Transcranial Electrotherapy Stimulator-a, Model Tesa-1.

Pre-market Notification Details

Device IDK024377
510k NumberK024377
Device Name:TRANSCRANIAL ELECTROTHERAPY STIMULATOR-A, MODEL TESA-1
ClassificationStimulator, Cranial Electrotherapy
Applicant KALACO SCIENTIFIC, INC. 131 GLENN WAY SUITE 7 San Carlos,  CA  94070
ContactGrace Bartoo
CorrespondentGrace Bartoo
KALACO SCIENTIFIC, INC. 131 GLENN WAY SUITE 7 San Carlos,  CA  94070
Product CodeJXK  
CFR Regulation Number882.5800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-12-31
Decision Date2003-07-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B788KS02000 K024377 000
B788KS02001 K024377 000

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