The following data is part of a premarket notification filed by Datex-ohmeda, Inc. with the FDA for Datex-ohmeda Network And Central.
Device ID | K000647 |
510k Number | K000647 |
Device Name: | DATEX-OHMEDA NETWORK AND CENTRAL |
Classification | System, Network And Communication, Physiological Monitors |
Applicant | DATEX-OHMEDA, INC. 3 HIGHWOOD DR. Tewksbury, MA 01876 |
Contact | Joel Kent |
Correspondent | Joel Kent DATEX-OHMEDA, INC. 3 HIGHWOOD DR. Tewksbury, MA 01876 |
Product Code | MSX |
CFR Regulation Number | 870.2300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-02-28 |
Decision Date | 2000-07-13 |