The following data is part of a premarket notification filed by Agilent Technologies Deutschland Gmbh with the FDA for Agilent Component Monitoring System, Agilent Multi-measurement Server And Compact Portable Patient Monitor, Agilent Noni.
| Device ID | K001333 |
| 510k Number | K001333 |
| Device Name: | AGILENT COMPONENT MONITORING SYSTEM, AGILENT MULTI-MEASUREMENT SERVER AND COMPACT PORTABLE PATIENT MONITOR, AGILENT NONI |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-04-27 |
| Decision Date | 2000-05-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838050099 | K001333 | 000 |
| 20884838037704 | K001333 | 000 |
| 20884838037711 | K001333 | 000 |
| 20884838037742 | K001333 | 000 |
| 20884838037759 | K001333 | 000 |
| 20884838037766 | K001333 | 000 |
| 20884838037773 | K001333 | 000 |
| 00884838050075 | K001333 | 000 |
| 00884838050082 | K001333 | 000 |
| 20884838037681 | K001333 | 000 |