The following data is part of a premarket notification filed by Katecho, Inc. with the FDA for Defib K-pads.
Device ID | K895662 |
510k Number | K895662 |
Device Name: | DEFIB K-PADS |
Classification | Dc-defibrillator, Low-energy, (including Paddles) |
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 | LDD |
CFR Regulation Number | 870.5300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-09-20 |
Decision Date | 1990-01-18 |