The following data is part of a premarket notification filed by Btl Industries, Inc with the FDA for Am-100.
Device ID | K163165 |
510k Number | K163165 |
Device Name: | AM-100 |
Classification | Stimulator, Muscle, Powered, For Muscle Conditioning |
Applicant | BTL INDUSTRIES, INC 47 Loring Drive Framington, MA 01702 |
Contact | David Chmel |
Correspondent | David Chmel BTL INDUSTRIES, INC 47 Loring Drive Framington, MA 01702 |
Product Code | NGX |
CFR Regulation Number | 890.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-11-10 |
Decision Date | 2017-02-16 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
AM-100 73240458 1228912 Dead/Cancelled |
Alpha Microsystems 1979-11-26 |
AM-100 73240418 1228925 Dead/Cancelled |
Alpha Microsystems 1979-11-26 |