The following data is part of a premarket notification filed by Cardio Medical Products, Inc. with the FDA for Cardiomed.
Device ID | K103651 |
510k Number | K103651 |
Device Name: | CARDIOMED |
Classification | Dc-defibrillator, Low-energy, (including Paddles) |
Applicant | CARDIO MEDICAL PRODUCTS, INC. 385 FRANKLIN AVE. STE. L Rockaway, NJ 07866 |
Contact | Nick Mendise |
Correspondent | Nick Mendise CARDIO MEDICAL PRODUCTS, INC. 385 FRANKLIN AVE. STE. L Rockaway, NJ 07866 |
Product Code | LDD |
CFR Regulation Number | 870.5300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-12-14 |
Decision Date | 2011-10-04 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10814907020323 | K103651 | 000 |
10814907020255 | K103651 | 000 |
10814907020194 | K103651 | 000 |
10814907020125 | K103651 | 000 |
10814907020040 | K103651 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
CARDIOMED 74122079 1686222 Dead/Cancelled |
Cardiomed 1990-12-10 |
CARDIOMED 73715277 1509896 Dead/Cancelled |
NATURE'S WAY PRODUCTS, INC. 1988-03-07 |