510(k) K141967
K141967 is an FDA 510(k) premarket notification submitted by Inovo, Inc. for the device "PUREFILL OXYGEN COMPRESSOR". The FDA issued a decision of Substantially Equivalent on November 7, 2014. The device falls under product code CAW (Generator, Oxygen, Portable), a Class II device regulated under 21 CFR 868.5440. Inovo, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 7, 2014
- Date Received
- July 21, 2014
- 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