510(k) K063454
K063454 is an FDA 510(k) premarket notification submitted by On Site Gas Systems, Inc. for the device "POGS, MODEL 33C". The FDA issued a decision of Substantially Equivalent on May 9, 2007. 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
- May 9, 2007
- Date Received
- November 15, 2006
- 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