FDA 510(k)
FDA class 2
Substantially Equivalent
🇲🇾 Malaysia
CO2-Mas, Oxygen Delivery/ CO2 sampling cannula style, CO2 sampling only style
K Number: K143127
·
Decision Feb 13, 2015
Classifications
1
FEI Numbers
217
Registration Numbers
217
Same Product Code
304
Applicant Total
1
Review Days
105
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Basic Information
- Device Name
- CO2-Mas, Oxygen Delivery/ CO2 sampling cannula style, CO2 sampling only style
- K Number
- K143127
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1400
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dispo-Med (Malaysia) Sdn Bhd
- Date Received
- October 31, 2014
- Decision Date
- February 13, 2015
- Product Code
- CCK
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | FDA class 2 | Anesthesiology |
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