The following data is part of a premarket notification filed by Vibrant Health with the FDA for Eav Combi-2.
Device ID | K020565 |
510k Number | K020565 |
Device Name: | EAV COMBI-2 |
Classification | Device, Galvanic Skin Response Measurement |
Applicant | VIBRANT HEALTH 150 DES GRANDS COTEAUX Beoeil, Quebec, CA J3g 2c9 |
Contact | Stephen Emond |
Correspondent | Stephen Emond VIBRANT HEALTH 150 DES GRANDS COTEAUX Beoeil, 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 |