The following data is part of a premarket notification filed by Medical Devices, Inc. with the FDA for Dsx(tm), Digital Sx, Quantum Dsx, Model 4700s.
| Device ID | K895473 |
| 510k Number | K895473 |
| Device Name: | DSX(TM), DIGITAL SX, QUANTUM DSX, MODEL 4700S |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | MEDICAL DEVICES, INC. 833 THIRD ST. SOUTHWEST St. Paul, MN 55112 |
| Contact | Bruce Macfarlane,phd |
| Correspondent | Bruce Macfarlane,phd MEDICAL DEVICES, INC. 833 THIRD ST. SOUTHWEST St. Paul, MN 55112 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-11 |
| Decision Date | 1989-12-08 |