510(k) K162433
K162433 is an FDA 510(k) premarket notification submitted by Oxus, Inc. for the device "GCE Zen-O Portable Oxygen Concentrator". The FDA issued a decision of Substantially Equivalent on May 24, 2017. The device falls under product code CAW (Generator, Oxygen, Portable), a Class II device regulated under 21 CFR 868.5440. Oxus, Inc. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 24, 2017
- Date Received
- Aug 31, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Generator, Oxygen, Portable
- Device Class
- Class II
- Regulation Number
- 868.5440
- Review Panel
- AN
- Submission Type
- 510(k)