The following data is part of a premarket notification filed by Philips Medical Systems, Inc. with the FDA for Philips Heartstart 12 Lead Transfer Station, Model 989803142521.
| Device ID | K071391 |
| 510k Number | K071391 |
| Device Name: | PHILIPS HEARTSTART 12 LEAD TRANSFER STATION, MODEL 989803142521 |
| Classification | System, Network And Communication, Physiological Monitors |
| Applicant | PHILIPS MEDICAL SYSTEMS, INC. 3000 MINUTEMAN RD. Andover, MA 01810 |
| Contact | Paul Schrader |
| Correspondent | Paul Schrader PHILIPS MEDICAL SYSTEMS, INC. 3000 MINUTEMAN RD. Andover, MA 01810 |
| Product Code | MSX |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-05-18 |
| Decision Date | 2007-09-07 |
| Summary: | summary |