CPR PLUS

Aid, Cardiopulmonary Resuscitation

KELLS MEDICAL, INC.

The following data is part of a premarket notification filed by Kells Medical, Inc. with the FDA for Cpr Plus.

Pre-market Notification Details

• Device ID: K926333
• 510k Number: K926333
• Device Name: CPR PLUS
• Classification: Aid, Cardiopulmonary Resuscitation
• Applicant: KELLS MEDICAL, INC. C/O LAW OFC. KELLER & HECKMAN 1001 G ST., N.W., STE 500 WEST Washington, DC 20001
• Contact: John B Dunbeck
• Correspondent: John B Dunbeck; KELLS MEDICAL, INC. C/O LAW OFC. KELLER & HECKMAN 1001 G ST., N.W., STE 500 WEST Washington, DC 20001
• Product Code: LIX
• CFR Regulation Number: 870.5210 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1992-12-16
• Decision Date: 1993-11-08