The following data is part of a premarket notification filed by General Electric Medical Systems Information Techn with the FDA for Unity Network Id.
Device ID | K021454 |
510k Number | K021454 |
Device Name: | UNITY NETWORK ID |
Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
Applicant | GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
Contact | Joelle Neider |
Correspondent | Joelle Neider GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
Product Code | MWI |
CFR Regulation Number | 870.2300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-05-06 |
Decision Date | 2002-10-01 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00840682104500 | K021454 | 000 |
00840682104630 | K021454 | 000 |
00840682104623 | K021454 | 000 |
00840682104616 | K021454 | 000 |
00840682104609 | K021454 | 000 |
00840682104593 | K021454 | 000 |
00840682104586 | K021454 | 000 |
00840682104579 | K021454 | 000 |
00840682104562 | K021454 | 000 |
00840682104555 | K021454 | 000 |
00840682104548 | K021454 | 000 |
00840682104531 | K021454 | 000 |
00840682104524 | K021454 | 000 |
00840682104647 | K021454 | 000 |
00840682104654 | K021454 | 000 |
00840682104661 | K021454 | 000 |
00840682105408 | K021454 | 000 |
00840682105217 | K021454 | 000 |
00840682104777 | K021454 | 000 |
00840682104760 | K021454 | 000 |
00840682104753 | K021454 | 000 |
00840682104746 | K021454 | 000 |
00840682104722 | K021454 | 000 |
00840682104715 | K021454 | 000 |
00840682104708 | K021454 | 000 |
00840682104692 | K021454 | 000 |
00840682104685 | K021454 | 000 |
00840682104678 | K021454 | 000 |
00840682104517 | K021454 | 000 |