GEL-TAC

Pacemaker, Cardiac, External Transcutaneous (non-invasive)

KATECHO, INC.

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

Pre-market Notification Details

• Device ID: K915328
• 510k Number: K915328
• Device Name: GEL-TAC
• Classification: Pacemaker, Cardiac, External Transcutaneous (non-invasive)
• 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: DRO
• CFR Regulation Number: 870.5550 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1991-11-26
• Decision Date: 1992-06-29