Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2246340

FEI Number

2246340

Entity Name

CARDIO MEDICAL PRODUCTS, INC.

City/State/Country

ROCKAWAY, NJ, US

Establishment Address

385 Franklin Ave Ste L, ROCKAWAY, NJ 07866, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

CARDIO MEDICAL PRODUCTS, INC. (Owner Number: 2246340)

Owner / Operator Contact Address

385 FRANKLIN AVE. STE. L, --, Rockaway, NJ 07866, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K103159

PMA Number

N/A

All Registered Proprietary Names

Cardio Clear ScatPad Cardio Clear

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LDD	Dc-Defibrillator, Low-Energy, (Including Paddles)	Cardiovascular	Class 2	870.5300	2012-04-06
IWX	Barrier, Control Panel, X-Ray, Movable	Radiology	Class 1	892.6500	2013-01-16
LDD	Dc-Defibrillator, Low-Energy, (Including Paddles)	Cardiovascular	Class 2	870.5300	2015-02-25

Official Correspondent

Victoria Mackie

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

CARDIO MEDICAL PRODUCTS, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K203231	Philips North America, LLC	Switched Internal Paddles	2021-01-11
K200849	Remote Diagnostic Technologies, Ltd. A Philips Company	Tempus LS - Manual	2020-07-24

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0557-2025	Remote Diagnostic Technologies Ltd. Farnborough Aerospace Centre Aerospace Boulevard Farnborough United Kingdom	2	Tempus LS-Manual Defibrillator Model 00-3020 The Tempus LS-Manual is a defibrillator that can deliver a shock in manual or Pacemaker mode
Z-0564-2021	Remote Diagnostic Technologies Ltd. PAVILION C2, ASHWOOD PARK ASHWOOD WAY Basingstoke United Kingdom	2	Tempus LS - Manual Defibrillator, Model Number: 00-3020 Software Version: 1.3.4 - Product Usage: The device is intended to be used in the following environmental: - Primarily in pre-hospital care and transport applications (including ambulances, fixed and rotary wing aircraft).
Z-0861-2022	Remote Diagnostic Technologies Ltd. PAVILION C2, ASHWOOD PARK ASHWOOD WAY Basingstoke United Kingdom	2	Tempus LS, Type DGE1, CAT 00-3010, REF 3.940590, Software version 1.3.5, UDI: (01)07613365001693
Z-1825-2023	Remote Diagnostic Technologies Ltd. Farnborough Aerospace Centre Aerospace Boulevard Farnborough United Kingdom	2	Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020
Z-2028-2024	Remote Diagnostic Technologies Ltd. Farnborough Aerospace Centre Aerospace Boulevard Farnborough United Kingdom	2	Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020 when using Tempus LS-Manual User/Operator Manual

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2246340. Last updated year: 2026. Please use registration number 2246340 when referencing this establishment in official correspondence.