The following data is part of a premarket notification filed by Verimed Holdings, Inc. with the FDA for Verimed Myoexorciser Iii (myo Iii).
Device ID | K892649 |
510k Number | K892649 |
Device Name: | VERIMED MYOEXORCISER III (MYO III) |
Classification | Device, Biofeedback |
Applicant | VERIMED HOLDINGS, INC. 1001 N.W. 62ND STREET, SUITE 212 Fort Lauderdale, FL 33309 |
Contact | William Mee |
Correspondent | William Mee VERIMED HOLDINGS, INC. 1001 N.W. 62ND STREET, SUITE 212 Fort Lauderdale, FL 33309 |
Product Code | HCC |
CFR Regulation Number | 882.5050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-04-12 |
Decision Date | 1989-12-13 |