510(k) K020362

P.O.G.S. 3.3 PORTABLE OXYGEN GENERATOR SYSTEM by On Site Gas Systems, Inc. — Product Code CAW

K020362 is an FDA 510(k) premarket notification submitted by On Site Gas Systems, Inc. for the device "P.O.G.S. 3.3 PORTABLE OXYGEN GENERATOR SYSTEM". The FDA issued a decision of Substantially Equivalent on February 12, 2002. The device falls under product code CAW (Generator, Oxygen, Portable), a Class II device regulated under 21 CFR 868.5440. On Site Gas Systems, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 2002
Date Received
February 4, 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