K-SNAP

Electrode, Electrocardiograph

KATECHO, INC.

The following data is part of a premarket notification filed by Katecho, Inc. with the FDA for K-snap.

Pre-market Notification Details

• Device ID: K940586
• 510k Number: K940586
• Device Name: K-SNAP
• 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: 1994-02-08
• Decision Date: 1994-06-09