The following data is part of a premarket notification filed by Virbrant Health with the FDA for Eav Kindling 2000s Gsr Device.
Device ID | K020564 |
510k Number | K020564 |
Device Name: | EAV KINDLING 2000S GSR DEVICE |
Classification | Device, Galvanic Skin Response Measurement |
Applicant | VIRBRANT HEALTH 150 DES GRANDS COTEAUX Beloeil, Quebec, CA J3g 2c9 |
Contact | Stephen Emond |
Correspondent | Stephen Emond VIRBRANT HEALTH 150 DES GRANDS COTEAUX Beloeil, Quebec, CA J3g 2c9 |
Product Code | GZO |
CFR Regulation Number | 882.1540 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-02-20 |
Decision Date | 2002-04-30 |