The following data is part of a premarket notification filed by Bloomex International, Inc. with the FDA for Minitone.
Device ID | K810975 |
510k Number | K810975 |
Device Name: | MINITONE |
Classification | Stimulator, Muscle, Powered |
Applicant | BLOOMEX INTERNATIONAL, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | IPF |
CFR Regulation Number | 890.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-04-10 |
Decision Date | 1981-06-12 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
MINITONE 73288280 1178991 Dead/Cancelled |
Slendertone Limited 1980-12-03 |