CARDIOMED

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

CARDIO MEDICAL PRODUCTS, INC.

The following data is part of a premarket notification filed by Cardio Medical Products, Inc. with the FDA for Cardiomed.

Pre-market Notification Details

Device IDK103651
510k NumberK103651
Device Name:CARDIOMED
ClassificationDc-defibrillator, Low-energy, (including Paddles)
Applicant CARDIO MEDICAL PRODUCTS, INC. 385 FRANKLIN AVE. STE. L Rockaway,  NJ  07866
ContactNick Mendise
CorrespondentNick Mendise
CARDIO MEDICAL PRODUCTS, INC. 385 FRANKLIN AVE. STE. L Rockaway,  NJ  07866
Product CodeLDD  
CFR Regulation Number870.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-12-14
Decision Date2011-10-04
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10814907020323 K103651 000
10814907020255 K103651 000
10814907020194 K103651 000
10814907020125 K103651 000
10814907020040 K103651 000

Trademark Results [CARDIOMED]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CARDIOMED
CARDIOMED
74122079 1686222 Dead/Cancelled
Cardiomed
1990-12-10
CARDIOMED
CARDIOMED
73715277 1509896 Dead/Cancelled
NATURE'S WAY PRODUCTS, INC.
1988-03-07

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