510(k) K132205
K132205 is an FDA 510(k) premarket notification submitted by Inova Labs, Inc. for the device "ACTOVOX DUO2 OXYGEN CONCENTRATOR SYSTEM". The FDA issued a decision of Substantially Equivalent on Jun 6, 2014. The device falls under product code CAW (Generator, Oxygen, Portable), a Class II device regulated under 21 CFR 868.5440. Inova Labs, Inc. has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 6, 2014
- Date Received
- Jul 16, 2013
- 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)