The following data is part of a premarket notification filed by Philips Medical Systems, Inc. with the FDA for Philips Pagewriter Touch Cardiograph, Model M5000a Series.
| Device ID | K020708 |
| 510k Number | K020708 |
| Device Name: | PHILIPS PAGEWRITER TOUCH CARDIOGRAPH, MODEL M5000A SERIES |
| Classification | Electrocardiograph |
| Applicant | PHILIPS MEDICAL SYSTEMS, INC. 3000 MINUTEMAN RD. Andover, MA 01810 -1099 |
| Contact | Songhua Zhang |
| Correspondent | N.e. Devine ENTELA, INC. 3033 MADISON AVENUE, SE Grand Rapids, MI 49548 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2002-03-05 |
| Decision Date | 2002-04-25 |
| Summary: | summary |