The following data is part of a premarket notification filed by Cardio Medical Products, Inc. with the FDA for Cardio Med Model A102, H104, O101, P103, And Z100.
| Device ID | K103159 |
| 510k Number | K103159 |
| Device Name: | CARDIO MED MODEL A102, H104, O101, P103, AND Z100 |
| 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 | 2010-10-26 |
| Decision Date | 2011-01-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10814907020316 | K103159 | 000 |
| 10814907020033 | K103159 | 000 |
| 10814907020057 | K103159 | 000 |
| 10814907020064 | K103159 | 000 |
| 10814907020071 | K103159 | 000 |
| 10814907020118 | K103159 | 000 |
| 10814907020156 | K103159 | 000 |
| 10814907020187 | K103159 | 000 |
| 10814907020200 | K103159 | 000 |
| 10814907020217 | K103159 | 000 |
| 10814907020248 | K103159 | 000 |
| 10814907020262 | K103159 | 000 |
| 10814907020279 | K103159 | 000 |
| 10814907020286 | K103159 | 000 |
| 10814907020293 | K103159 | 000 |
| 00814907020005 | K103159 | 000 |