The following data is part of a premarket notification filed by Classic Medical Products, Inc. with the FDA for Classic Resting Silver-silverchloride Electrode.
| Device ID | K862953 |
| 510k Number | K862953 |
| Device Name: | CLASSIC RESTING SILVER-SILVERCHLORIDE ELECTRODE |
| Classification | Monitor, Blood-gas, On-line, Cardiopulmonary Bypass |
| Applicant | CLASSIC MEDICAL PRODUCTS, INC. S82 W 19246 APOLLO DR. Muskego, WI 53150 |
| Contact | Robert A Macur |
| Correspondent | Robert A Macur CLASSIC MEDICAL PRODUCTS, INC. S82 W 19246 APOLLO DR. Muskego, WI 53150 |
| Product Code | DRY |
| CFR Regulation Number | 870.4330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-08-05 |
| Decision Date | 1986-08-25 |