Cardiomed

FDA 510(k) K103651 · Cardio Medical Products, Inc.

Substantially Equivalent

510(k) numberK103651

Submission

Device name
Cardiomed
Applicant
Cardio Medical Products, Inc.
Rockaway, NJ, US
Received
December 14, 2010
Decision date
October 4, 2011
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LDD – Dc-Defibrillator, Low-Energy, (Including Paddles)
Device class
Class II (moderate risk)
Regulation
21 CFR 870.5300
Specialty
Cardiovascular
Life-sustaining
Yes

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K150349Rapid Hair Removal PadsLDD · Traditional Full Power Aed07/14/2015SE
K140502Zoll E Series AlsLDD · Traditional ZOLL Medical Corporation11/06/2014SE
K103783Euro Defi Pads Adult; Euro Defi Pads Adult Radiotransparent: Euro Defi Pads PediatricLDD · Traditional Fiab Spa06/16/2011SE
K103334Cardio MedLDD · Traditional Cardio Medical Products, Inc.01/18/2011SE
K103159Cardio Med Model A102, H104, O101, P103, and Z100LDD · Traditional Cardio Medical Products, Inc.01/11/2011SE
K102468Zoll Propaq MDLDD · Special Zoll Medical Corporation, World Wide Headquarters09/30/2010SE
K100654Zoll Propaq MDLDD · Traditional Zoll Medical Corporation, World Wide Headquarters07/29/2010SE

More from Zoll Medical Corporation, World Wide Headquarters

510(k)DeviceDecision
K103334Cardio MedLDD · Traditional 01/18/2011SE
K103159Cardio Med Model A102, H104, O101, P103, and Z100LDD · Traditional 01/11/2011SE

Questions and answers

When was Cardiomed cleared by the FDA?

Cardiomed (K103651) received a 510(k) decision of Substantially Equivalent on October 4, 2011, 294 days after the submission was received.

What is the product code of K103651?

The FDA product code is LDD – Dc-Defibrillator, Low-Energy, (Including Paddles), a Class II (moderate risk) device regulated under 21 CFR 870.5300.