The following data is part of a premarket notification filed by Quantitative Medicine, Inc. with the FDA for Q-sd.
Device ID | K923255 |
510k Number | K923255 |
Device Name: | Q-SD |
Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
Applicant | QUANTITATIVE MEDICINE, INC. 1870 NORTH STATE RD. 7 Matgate, FL 33063 |
Contact | Robert W Wolfgang |
Correspondent | Robert W Wolfgang QUANTITATIVE MEDICINE, INC. 1870 NORTH STATE RD. 7 Matgate, FL 33063 |
Product Code | GZJ |
CFR Regulation Number | 882.5890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-07-02 |
Decision Date | 1992-10-05 |