The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Datex-ohmeda Network And Icentral '05, Sales Revision 4.3.
Device ID | K052972 |
510k Number | K052972 |
Device Name: | DATEX-OHMEDA NETWORK AND ICENTRAL '05, SALES REVISION 4.3 |
Classification | System, Network And Communication, Physiological Monitors |
Applicant | GE HEALTHCARE 86 PILGRIM ROAD Needham, MA 02492 |
Contact | Joel Kent |
Correspondent | Joel Kent GE HEALTHCARE 86 PILGRIM ROAD Needham, MA 02492 |
Product Code | MSX |
CFR Regulation Number | 870.2300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-10-24 |
Decision Date | 2005-12-29 |
Summary: | summary |