Oxy2Pro
FDA 510(k) K222511 · Southmedic, Inc.
510(k) numberK222511
Submission
- Device name
- Oxy2Pro
- Applicant
- Southmedic, Inc.
Barrie, CA - Received
- August 19, 2022
- Decision date
- November 21, 2023
- 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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| K863318 | Aerosol-TBZA · Traditional | 09/11/1986SE |
| K861839 | VapofilCAD · Traditional | 05/21/1986SE |
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Questions and answers
When was Oxy2Pro cleared by the FDA?
Oxy2Pro (K222511) received a 510(k) decision of Substantially Equivalent on November 21, 2023, 459 days after the submission was received.
What is the product code of K222511?
The FDA product code is CCK – Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, a Class II (moderate risk) device regulated under 21 CFR 868.1400.