The following data is part of a premarket notification filed by Verimed Holdings, Inc. with the FDA for Myoexorciser Ii Fual.
Device ID | K951969 |
510k Number | K951969 |
Device Name: | MYOEXORCISER II FUAL |
Classification | Device, Biofeedback |
Applicant | VERIMED HOLDINGS, INC. 11950 N.W. 39TH ST., SUITE D Coral Springs, FL 33065 |
Contact | Christopher J Chase |
Correspondent | Christopher J Chase VERIMED HOLDINGS, INC. 11950 N.W. 39TH ST., SUITE D Coral Springs, FL 33065 |
Product Code | HCC |
CFR Regulation Number | 882.5050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-04-27 |
Decision Date | 1995-06-14 |