The following data is part of a premarket notification filed by Katecho, Inc. with the FDA for K-defib/pace Adult Electrode, Model Kdp-85.
| Device ID | K012404 |
| 510k Number | K012404 |
| Device Name: | K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-85 |
| Classification | Pacemaker, Cardiac, External Transcutaneous (non-invasive) |
| Applicant | KATECHO, INC. 2500 BELL AVE. P.O. BOX 21247 Des Moines, IA 50321 |
| Contact | Warren R Walters |
| Correspondent | Warren R Walters KATECHO, INC. 2500 BELL AVE. P.O. BOX 21247 Des Moines, IA 50321 |
| Product Code | DRO |
| CFR Regulation Number | 870.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-30 |
| Decision Date | 2001-10-12 |