The following data is part of a premarket notification filed by Ge Medical Systems Information Technologies with the FDA for Modification To: Unity Network Id.
| Device ID | K071982 |
| 510k Number | K071982 |
| Device Name: | MODIFICATION TO: UNITY NETWORK ID |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
| Contact | Lisa M Baumhardt |
| Correspondent | Lisa M Baumhardt GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
| Product Code | MWI |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-19 |
| Decision Date | 2007-09-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682122610 | K071982 | 000 |
| 00840682122467 | K071982 | 000 |
| 00840682122474 | K071982 | 000 |
| 00840682122481 | K071982 | 000 |
| 00840682122498 | K071982 | 000 |
| 00840682122504 | K071982 | 000 |
| 00840682122511 | K071982 | 000 |
| 00840682122528 | K071982 | 000 |
| 00840682122535 | K071982 | 000 |
| 00840682122542 | K071982 | 000 |
| 00840682122559 | K071982 | 000 |
| 00840682122566 | K071982 | 000 |
| 00840682122573 | K071982 | 000 |
| 00840682122597 | K071982 | 000 |
| 00840682122450 | K071982 | 000 |