The following data is part of a premarket notification filed by Hill-rom Manufacturing, Inc. with the FDA for Modification To The Watchchild Obstetrical Patient Data Management System.
Device ID | K014094 |
510k Number | K014094 |
Device Name: | MODIFICATION TO THE WATCHCHILD OBSTETRICAL PATIENT DATA MANAGEMENT SYSTEM |
Classification | System, Monitoring, Perinatal |
Applicant | HILL-ROM MANUFACTURING, INC. 11000 REGENCY PKWY. WEST TOWER, SUITE 205 Cary, NC 27511 |
Contact | Cindy L Crosby |
Correspondent | Cindy L Crosby HILL-ROM MANUFACTURING, INC. 11000 REGENCY PKWY. WEST TOWER, SUITE 205 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 | 2001-12-12 |
Decision Date | 2002-01-11 |
Summary: | summary |