CARDIO MED
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 Cardio Med.
Pre-market Notification Details
| Device ID | K103334 |
| 510k Number | K103334 |
| Device Name: | CARDIO MED |
| 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 | 2010-11-15 |
| Decision Date | 2011-01-18 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10814907020231 | K103334 | 000 |
| 10814907020224 | K103334 | 000 |
| 10814907020170 | K103334 | 000 |
| 10814907020163 | K103334 | 000 |
| 10814907020101 | K103334 | 000 |
| 20814907020085 | K103334 | 000 |
| 10814907020026 | K103334 | 000 |
| 00814907020012 | K103334 | 000 |
Trademark Results [CARDIO MED]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CARDIO MED 76367257 2639472 Dead/Cancelled |
Cardio-Med Ltd. 2002-02-05 |
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