Biochem 8100 Anesthetic Agent Monitor
FDA 510(k) K892646 · Biochem International, Inc.
510(k) numberK892646
Submission
- Device name
- Biochem 8100 Anesthetic Agent Monitor
- Applicant
- Biochem International, Inc.
Waukesha, WI, US - Received
- April 12, 1989
- Decision date
- August 31, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K994188 | Modification to Agilent Technologies Anesthesia Gas Monitor, Model M1026A #CO5CBQ · Special | Agilent Technologies, GmbH | 05/19/2000SE |
| 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 |
More from Bruel & Kjaer
| 510(k) | Device | Decision |
|---|---|---|
| K920083 | Biochem Model 3302 NEWOX2 OximeterDQA · Traditional | 04/11/1994SE |
| K932389 | 8100 Anesthetic Agent MonitorCBS · Traditional | 12/03/1993SE |
| K921388 | Biochem 9100 Multigas Monitor Ibp ModuleDSK · Traditional | 05/26/1993SE |
| K920082 | Biochem Model 3301 NEWOX1 OximeterDQA · Traditional | 01/07/1993SE |
| K911351 | Biochem 9100 Multigas Monitor TEMP/FIO1 Mod,NibpDXN · Traditional | 08/22/1991SE |
| K910381 | Biochem Temperature/ FIO2 ModuleCCL · Traditional | 08/22/1991SE |
| K903222 | Biochem 6100 Non-Invasive MonitorDXN · Traditional | 09/04/1990SE |
| K901861 | Biochem 9100 Multigas MonitorCCK · Traditional | 07/27/1990SE |
| K893877 | Biochem 3100 OximeterDQO · Traditional | 12/20/1989SE |
| K890874 | Biochem 520 Breath IndicatorCCK · Traditional | 06/15/1989SE |
Questions and answers
When was Biochem 8100 Anesthetic Agent Monitor cleared by the FDA?
Biochem 8100 Anesthetic Agent Monitor (K892646) received a 510(k) decision of Substantially Equivalent on August 31, 1989, 141 days after the submission was received.
What is the product code of K892646?
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.