The following data is part of a premarket notification filed by Webster Laboratories, Inc. with the FDA for Switching Unit Electrode Catheters.
| Device ID | K823361 |
| 510k Number | K823361 |
| Device Name: | SWITCHING UNIT ELECTRODE CATHETERS |
| Classification | Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Applicant | WEBSTER LABORATORIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DRF |
| CFR Regulation Number | 870.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-11-09 |
| Decision Date | 1983-01-14 |