The following data is part of a premarket notification filed by Philips Medical Systems with the FDA for Philips Ecg Leadwire Set.
| Device ID | K110287 |
| 510k Number | K110287 |
| Device Name: | PHILIPS ECG LEADWIRE SET |
| Classification | Cable, Transducer And Electrode, Patient, (including Connector) |
| Applicant | PHILIPS MEDICAL SYSTEMS 3000 MINUTEMAN RD. Andover, MA 01810 -1099 |
| Contact | Peter Schipelliti |
| Correspondent | Dawn Tibodeau TUV SUD AMERICA INC. 1775 OLD HIGHWAY 8 NW New Brighton, MN 55112 -1891 |
| Product Code | DSA |
| CFR Regulation Number | 870.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2011-01-31 |
| Decision Date | 2011-02-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838034211 | K110287 | 000 |
| 20884838072439 | K110287 | 000 |
| 20884838072446 | K110287 | 000 |
| 20884838075683 | K110287 | 000 |
| 20884838075690 | K110287 | 000 |
| 20884838075706 | K110287 | 000 |
| 20884838075713 | K110287 | 000 |
| 20884838075720 | K110287 | 000 |
| 20884838075737 | K110287 | 000 |
| 20884838075744 | K110287 | 000 |
| 20884838075751 | K110287 | 000 |
| 00884838025516 | K110287 | 000 |
| 00884838025523 | K110287 | 000 |
| 00884838025530 | K110287 | 000 |
| 00884838025547 | K110287 | 000 |
| 00884838034204 | K110287 | 000 |
| 00884838026766 | K110287 | 000 |