The following data is part of a premarket notification filed by Agilent Technologies Deutschland Gmbh with the FDA for Agilent Component Monitoring System, Agilent Cardiac Output Module, Agilent Invasive Pressure Module, Model M1175a/76a.
| Device ID | K002758 |
| 510k Number | K002758 |
| Device Name: | AGILENT COMPONENT MONITORING SYSTEM, AGILENT CARDIAC OUTPUT MODULE, AGILENT INVASIVE PRESSURE MODULE, MODEL M1175A/76A |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | AGILENT TECHNOLOGIES DEUTSCHLAND GMBH HERRENBERGER ST. 130 BOEBLINGEN Boeblingen,, DE 71034 |
| Contact | Egon Pfeil |
| Correspondent | Egon Pfeil AGILENT TECHNOLOGIES DEUTSCHLAND GMBH HERRENBERGER ST. 130 BOEBLINGEN Boeblingen,, DE 71034 |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-09-05 |
| Decision Date | 2001-02-22 |