The following data is part of a premarket notification filed by Katecho, Inc. with the FDA for K-defib/pace Electrode.
| Device ID | K914955 |
| 510k Number | K914955 |
| Device Name: | K-DEFIB/PACE ELECTRODE |
| Classification | Pacemaker, Cardiac, External Transcutaneous (non-invasive) |
| Applicant | KATECHO, INC. 2601 BELL AVE. P.O BOX 21247 Des Moines, IA 50315 |
| Contact | Lorne Scharnberg |
| Correspondent | Lorne Scharnberg KATECHO, INC. 2601 BELL AVE. P.O BOX 21247 Des Moines, IA 50315 |
| Product Code | DRO |
| CFR Regulation Number | 870.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-05 |
| Decision Date | 1992-05-14 |