The following data is part of a premarket notification filed by Katecho, Inc. with the FDA for K-klip.
| Device ID | K940801 |
| 510k Number | K940801 |
| Device Name: | K-KLIP |
| Classification | Electrode, Electrocardiograph |
| 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 | DRX |
| CFR Regulation Number | 870.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-02-22 |
| Decision Date | 1994-08-03 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() K-KLIP 74097243 not registered Dead/Abandoned |
Baxter International Inc. 1990-09-17 |