K192852 is an FDA 510(k) clearance for the MRI ECG Patient Cable. This device is classified as a System, Nuclear Magnetic Resonance Imaging (Class II - Special Controls, product code LNH).
Submitted by Ivy Biomedical Systems, Inc. (Branford, US). The FDA issued a Cleared decision on March 28, 2020, 177 days after receiving the submission on October 3, 2019.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 892.1000.
| 510(k) Number | K192852 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 03, 2019 |
| Decision Date | March 28, 2020 |
| Days to Decision | 177 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| Product Code | LNH — System, Nuclear Magnetic Resonance Imaging |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1000 |