The following data is part of a premarket notification filed by Cadwell Laboratories, Inc. with the FDA for Cadwell Four-/eight-channel Preamplifier.
| Device ID | K962458 |
| 510k Number | K962458 |
| Device Name: | CADWELL FOUR-/EIGHT-CHANNEL PREAMPLIFIER |
| Classification | Stimulator, Electrical, Evoked Response |
| Applicant | CADWELL LABORATORIES, INC. 909 N. KELLOGG ST. Kennewick, WA 99336 |
| Contact | Leonard Ruff |
| Correspondent | Leonard Ruff CADWELL LABORATORIES, INC. 909 N. 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 | 1996-06-25 |
| Decision Date | 1997-01-13 |
| Summary: | summary |