The following data is part of a premarket notification filed by Datex-ohmeda with the FDA for Ge Datex-ohmeda S/5 Network And Icentral '03, Sales Revision 3.3.
Device ID | K042771 |
510k Number | K042771 |
Device Name: | GE DATEX-OHMEDA S/5 NETWORK AND ICENTRAL '03, SALES REVISION 3.3 |
Classification | System, Network And Communication, Physiological Monitors |
Applicant | DATEX-OHMEDA 86 PILGRIM RD. Needham, MA 02492 |
Contact | Joel Kent |
Correspondent | Joel Kent DATEX-OHMEDA 86 PILGRIM RD. 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 | 2004-10-05 |
Decision Date | 2004-10-15 |
Summary: | summary |