The following data is part of a premarket notification filed by Ge Healthcare Integrated It Solutions with the FDA for Centricity Perinatal And Centricity Intensive Care.
| Device ID | K111614 |
| 510k Number | K111614 |
| Device Name: | CENTRICITY PERINATAL AND CENTRICITY INTENSIVE CARE |
| Classification | System, Monitoring, Perinatal |
| Applicant | GE HEALTHCARE INTEGRATED IT SOLUTIONS 540 W. NW HIGHWAY Barrington, IL 60010 |
| Contact | Jeme Wallace |
| Correspondent | Jeme Wallace GE HEALTHCARE INTEGRATED IT SOLUTIONS 540 W. NW HIGHWAY Barrington, IL 60010 |
| Product Code | HGM |
| CFR Regulation Number | 884.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-08 |
| Decision Date | 2011-09-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682141642 | K111614 | 000 |
| 00840682123785 | K111614 | 000 |
| 00840682102681 | K111614 | 000 |
| 00195278454386 | K111614 | 000 |