510(k) K071928

THE INVACARE FLYER, MODEL IPC 100 by Invacare Corp. — Product Code CAW

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