The following data is part of a premarket notification filed by Philips Medical Systems with the FDA for Pagewriter Cardiograph.
| Device ID | K080999 |
| 510k Number | K080999 |
| Device Name: | PAGEWRITER CARDIOGRAPH |
| Classification | Electrocardiograph |
| Applicant | PHILIPS MEDICAL SYSTEMS 3000 MINUTEMAN RD. Andover, MA 01810 -1099 |
| Contact | Paul Schrader |
| Correspondent | Paul Schrader PHILIPS MEDICAL SYSTEMS 3000 MINUTEMAN RD. Andover, MA 01810 -1099 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-08 |
| Decision Date | 2008-05-09 |
| Summary: | summary |