The following data is part of a premarket notification filed by Phoenix Medical Devices, Llp with the FDA for Theratrode.
Device ID | K112312 |
510k Number | K112312 |
Device Name: | THERATRODE |
Classification | Electrode, Cutaneous |
Applicant | PHOENIX MEDICAL DEVICES, LLP 2458 ALTON PARKWAY Irvine, CA 92606 |
Contact | Jim Klett |
Correspondent | Jim Klett PHOENIX MEDICAL DEVICES, LLP 2458 ALTON PARKWAY Irvine, CA 92606 |
Product Code | GXY |
CFR Regulation Number | 882.1320 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-08-11 |
Decision Date | 2012-01-25 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
THERATRODE 73389315 1264135 Dead/Cancelled |
W/R Medical Electronics Co. 1982-09-27 |