FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
Oxy2Pro
K Number: K222511
·
Decision Nov 21, 2023
Classifications
1
FEI Numbers
204
Registration Numbers
204
Same Product Code
301
Applicant Total
1
Review Days
459
Basic Information
- Device Name
- Oxy2Pro
- K Number
- K222511
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1400
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Southmedic Inc.
- Date Received
- August 19, 2022
- Decision Date
- November 21, 2023
- 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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