The following data is part of a premarket notification filed by Dr. Oliver Wenker, M.d., M.b.a. with the FDA for Futura.
Device ID | K102524 |
510k Number | K102524 |
Device Name: | FUTURA |
Classification | Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat |
Applicant | DR. OLIVER WENKER, M.D., M.B.A. 2300 VALLEY VIEW LANE, SUITE 230 Farmers Branch, TX 75234 |
Contact | Courtland Imel |
Correspondent | Courtland Imel DR. OLIVER WENKER, M.D., M.B.A. 2300 VALLEY VIEW LANE, SUITE 230 Farmers Branch, TX 75234 |
Product Code | IMG |
CFR Regulation Number | 890.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-09-02 |
Decision Date | 2011-11-03 |
Summary: | summary |