Datascope Multinex II
FDA 510(k) K926451 · Datascope Corp.
510(k) numberK926451
Submission
- Device name
- Datascope Multinex II
- Applicant
- Datascope Corp.
Paramus, NJ, US - Received
- December 24, 1992
- Decision date
- August 25, 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
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|---|---|---|---|
| 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 |
| 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 |
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Questions and answers
When was Datascope Multinex II cleared by the FDA?
Datascope Multinex II (K926451) received a 510(k) decision of Substantially Equivalent on August 25, 1993, 244 days after the submission was received.
What is the product code of K926451?
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.