Medley ETCO2 Module (Includes Accessories), Model 8300
FDA 510(k) K031741 · Alaris Medical Systems, Inc.
510(k) numberK031741
Submission
- Device name
- Medley ETCO2 Module (Includes Accessories), Model 8300
- Applicant
- Alaris Medical Systems, Inc.
San Diego, CA, US - Received
- June 4, 2003
- Decision date
- February 9, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CCK – Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1400
- Specialty
- Anesthesiology
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| K030459 | Medley System with Medication Management System (MMS)FRN · Traditional | 04/04/2003SE |
| K023264 | Medley Syringe Pump Module System, Model 8110FRN · Traditional | 12/19/2002SE |
| K022677 | Medley SPO2 Module, Model 8210 & SPO2 Sensors & CableDQA · Special | 09/11/2002SE |
| K022209 | Alaris Medical Infusion System Administration SetsFPA · Special | 08/06/2002SE |
| K013087 | Single Dose Dispensing Pin, Model 2201LHI · Traditional | 11/13/2001SE |
| K012383 | Gemini PC-1,PC-2, PC-2TX,PC-4, Signature Edition Infusion Pump (Se), Medsystem III…FRN · Traditional | 10/02/2001SE |
Questions and answers
When was Medley ETCO2 Module (Includes Accessories), Model 8300 cleared by the FDA?
Medley ETCO2 Module (Includes Accessories), Model 8300 (K031741) received a 510(k) decision of Substantially Equivalent on February 9, 2004, 250 days after the submission was received.
What is the product code of K031741?
The FDA product code is CCK – Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, a Class II (moderate risk) device regulated under 21 CFR 868.1400.