The following data is part of a premarket notification filed by Katecho, Inc. with the FDA for K-defib/pace Adult Electrode Model Number Kdp-60.
| Device ID | K981737 |
| 510k Number | K981737 |
| Device Name: | K-DEFIB/PACE ADULT ELECTRODE MODEL NUMBER KDP-60 |
| Classification | Automated External Defibrillators (non-wearable) |
| Applicant | KATECHO, INC. 2500 BELL AVE. P.O. BOX 21247 Des Moines, IA 50321 |
| Contact | Lorne S Charnberg |
| Correspondent | Lorne S Charnberg 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 | 1998-05-18 |
| Decision Date | 1998-12-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838022034 | K981737 | 000 |
| 00884838022010 | K981737 | 000 |