The following data is part of a premarket notification filed by Ge Medical Systems Information Technologies with the FDA for Solar 8000 And Transport Pro With Patient Data Module.
| Device ID | K071073 |
| 510k Number | K071073 |
| Device Name: | SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
| Contact | Karen M Lunde |
| Correspondent | Karen M Lunde GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
| Product Code | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-16 |
| Decision Date | 2007-05-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682118095 | K071073 | 000 |
| 00840682104814 | K071073 | 000 |
| 00840682104845 | K071073 | 000 |
| 00840682104852 | K071073 | 000 |
| 00840682104869 | K071073 | 000 |
| 00840682110440 | K071073 | 000 |
| 00840682117425 | K071073 | 000 |
| 00840682117531 | K071073 | 000 |
| 00840682117661 | K071073 | 000 |
| 00840682117678 | K071073 | 000 |
| 00840682118064 | K071073 | 000 |
| 00840682118156 | K071073 | 000 |
| 00840682104784 | K071073 | 000 |