The following data is part of a premarket notification filed by Katecho, Inc. with the FDA for K-defib/pace Radiolucent Adult Electrode, Model Krt-60.
| Device ID | K991007 |
| 510k Number | K991007 |
| Device Name: | K-DEFIB/PACE RADIOLUCENT ADULT ELECTRODE, MODEL KRT-60 |
| Classification | Automated External Defibrillators (non-wearable) |
| Applicant | KATECHO, INC. 2500 BELL AVE. P.O. BOX 21247 Des Moines, IA 50321 |
| Contact | Lorne Scharnberg |
| Correspondent | Lorne Scharnberg KATECHO, INC. 2500 BELL AVE. P.O. BOX 21247 Des Moines, IA 50321 |
| Product Code | MKJ |
| CFR Regulation Number | 870.5310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-26 |
| Decision Date | 1999-08-23 |