510(k) K071928
K071928 is an FDA 510(k) premarket notification submitted by Invacare Corp. for the device "THE INVACARE FLYER, MODEL IPC 100". The FDA issued a decision of Substantially Equivalent on December 12, 2007. The device falls under product code CAW (Generator, Oxygen, Portable), a Class II device regulated under 21 CFR 868.5440. Invacare Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 12, 2007
- Date Received
- July 12, 2007
- 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