The following data is part of a premarket notification filed by Katecho, Inc. with the FDA for Pediatric Defib K-pads.
| Device ID | K935083 |
| 510k Number | K935083 |
| Device Name: | PEDIATRIC DEFIB K-PADS |
| Classification | Dc-defibrillator, Low-energy, (including Paddles) |
| 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 | LDD |
| CFR Regulation Number | 870.5300 [🔎] |
| Decision | Se Subject To Tracking Reg (ST) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-25 |
| Decision Date | 1994-07-25 |