The following data is part of a premarket notification filed by Hill-rom Manufacturing, Inc. with the FDA for Navicare -watchchild Obstetrical Data Management System (navicare -watchchild), Model P2912.
| Device ID | K080226 |
| 510k Number | K080226 |
| Device Name: | NAVICARE -WATCHCHILD OBSTETRICAL DATA MANAGEMENT SYSTEM (NAVICARE -WATCHCHILD), MODEL P2912 |
| Classification | System, Monitoring, Perinatal |
| Applicant | HILL-ROM MANUFACTURING, INC. 1225 CRESCENT GREEN DR. SUITE 200 Cary, NC 27511 |
| Contact | Dawn M Reilly |
| Correspondent | Dawn M Reilly HILL-ROM MANUFACTURING, INC. 1225 CRESCENT GREEN DR. SUITE 200 Cary, NC 27511 |
| Product Code | HGM |
| CFR Regulation Number | 884.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-01-29 |
| Decision Date | 2008-04-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00862095000460 | K080226 | 000 |
| 00860003483527 | K080226 | 000 |
| 00860003483510 | K080226 | 000 |
| 00860003483503 | K080226 | 000 |
| 00862095000491 | K080226 | 000 |
| 00862095000484 | K080226 | 000 |
| 00862095000408 | K080226 | 000 |
| 00862095000415 | K080226 | 000 |
| 00862095000422 | K080226 | 000 |
| 00862095000439 | K080226 | 000 |
| 00862095000446 | K080226 | 000 |
| 00862095000453 | K080226 | 000 |
| 00862095000477 | K080226 | 000 |
| 00860003483558 | K080226 | 000 |