K-FREE

Dc-defibrillator, Low-energy, (including Paddles)

KATECHO, INC.

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

Pre-market Notification Details

• Device ID: K912587
• 510k Number: K912587
• Device Name: K-FREE
• 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: 1991-06-12
• Decision Date: 1991-07-30