The following data is part of a premarket notification filed by Agilent Technologies, Gmbh with the FDA for Modification To Agilent Technologies Anesthesia Gas Monitor, Model M1026a #co5.
Device ID | K994188 |
510k Number | K994188 |
Device Name: | MODIFICATION TO AGILENT TECHNOLOGIES ANESTHESIA GAS MONITOR, MODEL M1026A #CO5 |
Classification | Analyzer, Gas, Enflurane, Gaseous-phase (anesthetic Concentration) |
Applicant | AGILENT TECHNOLOGIES, GMBH HERRENBERGER STRASSE 130 Boeblingen, DE 71034 |
Contact | Herbert Van Dyk |
Correspondent | Herbert Van Dyk AGILENT TECHNOLOGIES, GMBH HERRENBERGER STRASSE 130 Boeblingen, DE 71034 |
Product Code | CBQ |
CFR Regulation Number | 868.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-12-13 |
Decision Date | 2000-05-19 |
Summary: | summary |