The following data is part of a premarket notification filed by Philips Medical Systems with the FDA for Pagewriter Tc 20, 30, 50, 70.
| Device ID | K113144 |
| 510k Number | K113144 |
| Device Name: | PAGEWRITER TC 20, 30, 50, 70 |
| Classification | Electrocardiograph |
| Applicant | PHILIPS MEDICAL SYSTEMS 3000 MINUTEMAN RD. Andover, MA 01810 -1099 |
| Contact | Paul Schrader |
| Correspondent | Dawn Tibodeau TUV SUD AMERICA INC. 1775 OLD HIGHWAY 8 NW New Brighton, MN 55112 -1891 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2011-10-25 |
| Decision Date | 2012-04-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838091702 | K113144 | 000 |
| 00884838026568 | K113144 | 000 |
| 00884838025509 | K113144 | 000 |
| 00884838025493 | K113144 | 000 |
| 00884838025486 | K113144 | 000 |
| 00884838025479 | K113144 | 000 |
| 00884838015005 | K113144 | 000 |
| 00884838014992 | K113144 | 000 |
| 00884838014985 | K113144 | 000 |
| 00884838014978 | K113144 | 000 |
| 00884838013162 | K113144 | 000 |
| 00884838013117 | K113144 | 000 |
| 00884838012806 | K113144 | 000 |
| 00884838012790 | K113144 | 000 |
| 00884838026582 | K113144 | 000 |
| 00884838028784 | K113144 | 000 |
| 00884838032514 | K113144 | 000 |
| 00884838091689 | K113144 | 000 |
| 00884838087293 | K113144 | 000 |
| 00884838087286 | K113144 | 000 |
| 00884838087279 | K113144 | 000 |
| 00884838087262 | K113144 | 000 |
| 00884838082007 | K113144 | 000 |
| 00884838081185 | K113144 | 000 |
| 00884838081178 | K113144 | 000 |
| 00884838081123 | K113144 | 000 |
| 00884838081116 | K113144 | 000 |
| 00884838080836 | K113144 | 000 |
| 00884838080829 | K113144 | 000 |
| 00884838032545 | K113144 | 000 |
| 20884838086832 | K113144 | 000 |