The following data is part of a premarket notification filed by Amest Corp. with the FDA for Mb System, Bioenergy Light Therapy.
Device ID | K030275 |
510k Number | K030275 |
Device Name: | MB SYSTEM, BIOENERGY LIGHT THERAPY |
Classification | Lamp, Infrared, Therapeutic Heating |
Applicant | AMEST CORP. 30394 ESPERANZA Rancho Santa Margarita, CA 92688 |
Contact | John Iest |
Correspondent | John Iest AMEST CORP. 30394 ESPERANZA Rancho Santa Margarita, CA 92688 |
Product Code | ILY |
CFR Regulation Number | 890.5500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-01-27 |
Decision Date | 2004-11-29 |
Summary: | summary |