K103651 is an FDA 510(k) clearance for the CARDIOMED. This device is classified as a Dc-defibrillator, Low-energy, (including Paddles) (Class II - Special Controls, product code LDD).
Submitted by Cardio Medical Products, Inc. (Rockaway, US). The FDA issued a Cleared decision on October 4, 2011, 294 days after receiving the submission on December 14, 2010.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5300.
| 510(k) Number | K103651 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 14, 2010 |
| Decision Date | October 04, 2011 |
| Days to Decision | 294 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | LDD — Dc-defibrillator, Low-energy, (including Paddles) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.5300 |