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.
Device ID | K024377 |
510k Number | K024377 |
Device Name: | TRANSCRANIAL ELECTROTHERAPY STIMULATOR-A, MODEL TESA-1 |
Classification | Stimulator, Cranial Electrotherapy |
Applicant | KALACO SCIENTIFIC, INC. 131 GLENN WAY SUITE 7 San Carlos, CA 94070 |
Contact | Grace Bartoo |
Correspondent | Grace Bartoo KALACO SCIENTIFIC, INC. 131 GLENN WAY SUITE 7 San Carlos, CA 94070 |
Product Code | JXK |
CFR Regulation Number | 882.5800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-12-31 |
Decision Date | 2003-07-21 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
B788KS02000 | K024377 | 000 |
B788KS02001 | K024377 | 000 |