The following data is part of a premarket notification filed by Datex-ohmeda with the FDA for Datex Ohmeda S/5 Network And Central (icentral) '03 With L-net03 Software.
Device ID | K033281 |
510k Number | K033281 |
Device Name: | DATEX OHMEDA S/5 NETWORK AND CENTRAL (ICENTRAL) '03 WITH L-NET03 SOFTWARE |
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 | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-10-14 |
Decision Date | 2003-11-26 |
Summary: | summary |