510(k) K021685

VENTURE HOMEFILL II WITH OXYGEN CONSERVER by Invacare Corp. — Product Code CAW

K021685 is an FDA 510(k) premarket notification submitted by Invacare Corp. for the device "VENTURE HOMEFILL II WITH OXYGEN CONSERVER". The FDA issued a decision of Substantially Equivalent on July 23, 2002. 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
July 23, 2002
Date Received
May 22, 2002
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