K110287 is an FDA 510(k) clearance for the PHILIPS ECG LEADWIRE SET. This device is classified as a Cable, Transducer And Electrode, Patient, (including Connector) (Class II - Special Controls, product code DSA).
Submitted by Philips Medical Systems (Andover, US). The FDA issued a Cleared decision on February 15, 2011, 15 days after receiving the submission on January 31, 2011.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2900.
| 510(k) Number | K110287 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 31, 2011 |
| Decision Date | February 15, 2011 |
| Days to Decision | 15 days |
| Submission Type | Abbreviated |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DSA — Cable, Transducer And Electrode, Patient, (including Connector) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2900 |