Cardio Med Model A102, H104, O101, P103, and Z100

Q: What is the product code of K103159?

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

FDA 510(k) K103159 · Cardio Medical Products, Inc.

Substantially Equivalent

510(k) numberK103159

Submission

Device name: Cardio Med Model A102, H104, O101, P103, and Z100
Applicant: Cardio Medical Products, Inc.
Rockaway, NJ, US
Received: October 26, 2010
Decision date: January 11, 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

Other 510(k)s with product code LDD

510(k)	Device	Applicant	Decision
K203231	Switched Internal PaddlesLDD · Special	Philips North America, LLC	01/11/2021SE
K200849	Tempus LS - ManualLDD · Traditional	Remote Diagnostic Technologies, Ltd. A Philips…	07/24/2020SE
K182503	Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitorsLDD · Traditional	Physio-Control, Inc.	06/03/2019SE
K150349	Rapid Hair Removal PadsLDD · Traditional	Full Power Aed	07/14/2015SE
K140502	Zoll E Series AlsLDD · Traditional	ZOLL Medical Corporation	11/06/2014SE
K103651	CardiomedLDD · Traditional	Cardio Medical Products, Inc.	10/04/2011SE
K103783	Euro Defi Pads Adult; Euro Defi Pads Adult Radiotransparent: Euro Defi Pads PediatricLDD · Traditional	Fiab Spa	06/16/2011SE
K103334	Cardio MedLDD · Traditional	Cardio Medical Products, Inc.	01/18/2011SE
K102468	Zoll Propaq MDLDD · Special	Zoll Medical Corporation, World Wide Headquarters	09/30/2010SE
K100654	Zoll Propaq MDLDD · Traditional	Zoll Medical Corporation, World Wide Headquarters	07/29/2010SE

More from Zoll Medical Corporation, World Wide Headquarters

510(k)	Device	Decision
K103651	CardiomedLDD · Traditional	10/04/2011SE
K103334	Cardio MedLDD · Traditional	01/18/2011SE

Questions and answers

When was Cardio Med Model A102, H104, O101, P103, and Z100 cleared by the FDA?

Cardio Med Model A102, H104, O101, P103, and Z100 (K103159) received a 510(k) decision of Substantially Equivalent on January 11, 2011, 77 days after the submission was received.

What is the product code of K103159?

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