The following data is part of a premarket notification filed by Agilent Technologies Deutschland Gmbh with the FDA for Agilent Component Monitoring System, Agilent V24/26, Agilent Bis Module, Model M1175a/76a/77a,rev.l,m1205a,rev.l,m1034a.
| Device ID | K003038 |
| 510k Number | K003038 |
| Device Name: | AGILENT COMPONENT MONITORING SYSTEM, AGILENT V24/26, AGILENT BIS MODULE, MODEL M1175A/76A/77A,REV.L,M1205A,REV.L,M1034A |
| Classification | Index-generating Electroencephalograph Software |
| 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 | OLW |
| Subsequent Product Code | OLT |
| Subsequent Product Code | OMC |
| Subsequent Product Code | ORT |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-09-29 |
| Decision Date | 2000-12-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838051515 | K003038 | 000 |
| 00884838021105 | K003038 | 000 |