The following data is part of a premarket notification filed by Cadwell Laboratories, Inc. with the FDA for Quantum 84.
| Device ID | K844707 |
| 510k Number | K844707 |
| Device Name: | QUANTUM 84 |
| Classification | Stimulator, Electrical, Evoked Response |
| Applicant | CADWELL LABORATORIES, INC. 909 NORTH KELLOGG ST. Kennewick, WA 99336 |
| Contact | Carlton M Cadwell |
| Correspondent | Carlton M Cadwell CADWELL LABORATORIES, INC. 909 NORTH KELLOGG ST. Kennewick, WA 99336 |
| Product Code | GWF |
| CFR Regulation Number | 882.1870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-12-03 |
| Decision Date | 1985-05-21 |