Modification to Agilent Technologies Anesthesia Gas Monitor, Model M1026A #CO5
FDA 510(k) K994188 · Agilent Technologies, GmbH
510(k) numberK994188
Submission
- Device name
- Modification to Agilent Technologies Anesthesia Gas Monitor, Model M1026A #CO5
- Applicant
- Agilent Technologies, GmbH
Boeblingen, DE - Received
- December 13, 1999
- Decision date
- May 19, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CBQ – Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1500
- Specialty
- Anesthesiology
Other 510(k)s with product code CBQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K040917 | Philips Anesthesia Gas Monitor, Model M1026BCBQ · Special | Philips Medizin Systeme Boeblingen GmbH | 04/29/2004SE |
| K962648 | Ohmeda Model 5330 Anesthetic Agent MonitorCBQ · Traditional | Ohmeda Medical | 01/17/1997SE |
| K931439 | Ohmeda Model 5330 Anesthetic MonitorCBQ · Traditional | Ohmeda Medical | 10/19/1993SE |
| K926451 | Datascope Multinex IICBQ · Traditional | Datascope Corp. | 08/25/1993SE |
| K923433 | AS/3 Anaesthesia Monitoring System Airway ModuleCBQ · Traditional | Instrumentarium Corp. | 07/22/1993SE |
| K923276 | Capnomac Ultima Anesthesia MonitorCBQ · Traditional | Datex Division Instrumentarium Corp. | 07/21/1993SE |
| K922876 | AS/3 Cop ModuleCBQ · Traditional | Datex Division Instrumentarium Corp. | 07/21/1993SE |
| K930303 | Datascope Multinex Id PlusCBQ · Traditional | Datascope Corp. | 06/16/1993SE |
| K914295 | Anesthetic Gas Monitor Type 1304, ModifiedCBQ · Traditional | Bruel & Kjaer | 04/10/1992SE |
| K911644 | NGM FrameCBQ · Traditional | Datex Division Instrumentarium Corp. | 03/04/1992SE |
More from Datex Division Instrumentarium Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K163367 | GenetiSure Dx Postnatal AssayPFX · Traditional | 08/11/2017SE |
| K010949 | 2010 Plus Holter for WindowsMLO · Traditional | 09/28/2001SE |
| K012094 | Modification to Device Link System, Model M2376AMWI · Special | 07/20/2001SE |
| K011824 | Agilent M2636B Telemon B Monitor (Telemon B)DSI · Special | 07/02/2001SE |
| K010634 | Heartstream XL Defibibrillator/Monitor, Model M4735A, Heartstream XLT…MKJ · Traditional | 06/11/2001SE |
| K011578 | M2376A Devicelink System, Model M2376AMWI · Special | 06/08/2001SE |
| K003819 | Heartstream Attenuated Defibrillation Pads, Model M3870AMKJ · Traditional | 05/02/2001SE |
| K011093 | Agilent Information Center Software for M3150,M3151,M3153 and M3154MHX · Special | 05/01/2001SE |
| K010453 | M2376A Devicelink SystemMWI · Special | 03/02/2001SE |
| K010342 | M2376A Devicelink System, Model M2376AMWI · Special | 02/14/2001SE |
Questions and answers
When was Modification to Agilent Technologies Anesthesia Gas Monitor, Model M1026A #CO5 cleared by the FDA?
Modification to Agilent Technologies Anesthesia Gas Monitor, Model M1026A #CO5 (K994188) received a 510(k) decision of Substantially Equivalent on May 19, 2000, 158 days after the submission was received.
What is the product code of K994188?
The FDA product code is CBQ – Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration), a Class II (moderate risk) device regulated under 21 CFR 868.1500.