The following data is part of a premarket notification filed by Katecho, Inc. with the FDA for K-defib/pace, Model Kdp-60a.
| Device ID | K002806 |
| 510k Number | K002806 |
| Device Name: | K-DEFIB/PACE, MODEL KDP-60A |
| Classification | Automated External Defibrillators (non-wearable) |
| 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 | MKJ |
| CFR Regulation Number | 870.5310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-09-08 |
| Decision Date | 2000-11-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838022041 | K002806 | 000 |
| 00884838002883 | K002806 | 000 |
| 00884838002876 | K002806 | 000 |
| 00884838002869 | K002806 | 000 |
| 00884838002852 | K002806 | 000 |
| 00884838002845 | K002806 | 000 |