AS/3 Anaesthesia Monitoring System Airway Module
FDA 510(k) K923433 · Instrumentarium Corp.
510(k) numberK923433
Submission
- Device name
- AS/3 Anaesthesia Monitoring System Airway Module
- Applicant
- Instrumentarium Corp.
Finland, FI - Received
- July 13, 1992
- Decision date
- July 22, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
| 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 |
| 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 |
|---|---|---|
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| K001439 | Orthoceph OC100 DMUH · Traditional | 06/22/2000SE |
| K992385 | Orthopantomograph OP100DMUH · Traditional | 09/28/1999SE |
| K981641 | Mammography X-Ray Equipment Models MGF101 and MGF110, Alpha III, Alpha ST, Alpha RT and…IZH · Traditional | 07/17/1998SE |
| K962638 | Tonocap, TC-200 and Accessory CathetersCCK · Traditional | 04/04/1997SE |
| K961441 | Tonometered Slaine Blood Gas ControlJJS · Traditional | 04/30/1996SE |
| K955018 | Trip NGS & Sigmoid Catheter Phi Slide CalculatorFFT · Traditional | 01/30/1996SE |
| K934478 | Alpha StereoIZH · Traditional | 01/31/1995SE |
| K930338 | Orthoceph OC100EHD · Traditional | 04/27/1993SE |
Questions and answers
When was AS/3 Anaesthesia Monitoring System Airway Module cleared by the FDA?
AS/3 Anaesthesia Monitoring System Airway Module (K923433) received a 510(k) decision of Substantially Equivalent on July 22, 1993, 374 days after the submission was received.
What is the product code of K923433?
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.