The following data is part of a premarket notification filed by Agilent Technologies, Gmbh with the FDA for Agilentcomponent Monitoring System, Agilent 24/26, Agilent Multi-measurement Server And Compact Portable Patient Monitor.
Device ID | K000822 |
510k Number | K000822 |
Device Name: | AGILENTCOMPONENT MONITORING SYSTEM, AGILENT 24/26, AGILENT MULTI-MEASUREMENT SERVER AND COMPACT PORTABLE PATIENT MONITOR |
Classification | Detector And Alarm, Arrhythmia |
Applicant | AGILENT TECHNOLOGIES, GMBH HERRENBERGERSTR. 130 Boeblingen, DE 71034 |
Contact | Egon Pfeil |
Correspondent | Egon Pfeil AGILENT TECHNOLOGIES, GMBH HERRENBERGERSTR. 130 Boeblingen, DE 71034 |
Product Code | DSI |
CFR Regulation Number | 870.1025 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-03-14 |
Decision Date | 2000-04-06 |