The following data is part of a premarket notification filed by Philips Medical Systems with the FDA for Philips Dxl 12/16-lead Ecg Algorithm.
| Device ID | K132068 |
| 510k Number | K132068 |
| Device Name: | PHILIPS DXL 12/16-LEAD ECG ALGORITHM |
| Classification | Electrocardiograph |
| Applicant | PHILIPS MEDICAL SYSTEMS 3000 MINUTEMAN RD Andover, MA 01810 |
| Contact | Theresa Poole |
| Correspondent | Theresa Poole PHILIPS MEDICAL SYSTEMS 3000 MINUTEMAN RD Andover, MA 01810 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-03 |
| Decision Date | 2013-09-26 |
| Summary: | summary |