The following data is part of a premarket notification filed by Quantitative Medicine, Inc. with the FDA for Q-ms Neuromuscular Stimulator.
| Device ID | K912462 |
| 510k Number | K912462 |
| Device Name: | Q-MS NEUROMUSCULAR STIMULATOR |
| Classification | Stimulator, Muscle, Powered |
| Applicant | QUANTITATIVE MEDICINE, INC. 1870 NORTH STATE RD. 7 Matgate, FL 33063 |
| Contact | York Mcgavin |
| Correspondent | York Mcgavin QUANTITATIVE MEDICINE, INC. 1870 NORTH STATE RD. 7 Matgate, FL 33063 |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-04 |
| Decision Date | 1992-06-04 |