Oxus Sieve Beds
FDA 510(k) K211056 · Oxus, Inc.
510(k) numberK211056
Submission
- Device name
- Oxus Sieve Beds
- Applicant
- Oxus, Inc.
Auburn Hills, MI, US - Received
- April 9, 2021
- Decision date
- May 31, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CAW – Generator, Oxygen, Portable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5440
- Specialty
- Anesthesiology
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| K250805 | DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW)CAW · Traditional | Devilbiss Healthcare, LLC | 12/09/2025SE |
More from Devilbiss Healthcare, LLC
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| K162433 | GCE Zen-O Portable Oxygen ConcentratorCAW · Traditional | 05/24/2017SE |
Questions and answers
When was Oxus Sieve Beds cleared by the FDA?
Oxus Sieve Beds (K211056) received a 510(k) decision of Substantially Equivalent on May 31, 2023, 782 days after the submission was received.
What is the product code of K211056?
The FDA product code is CAW – Generator, Oxygen, Portable, a Class II (moderate risk) device regulated under 21 CFR 868.5440.