The following data is part of a premarket notification filed by Agilent Technologies Deutschland Gmbh with the FDA for Agilent Component Monitoring System; Agilent Invasive Blood Pressure Module.
| Device ID | K001722 |
| 510k Number | K001722 |
| Device Name: | AGILENT COMPONENT MONITORING SYSTEM; AGILENT INVASIVE BLOOD PRESSURE MODULE |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| 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 | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-06-06 |
| Decision Date | 2000-06-30 |