510(k) K014078
K014078 is an FDA 510(k) premarket notification submitted by On Site Gas Systems, Inc. for the device "ON SITE GAS SYSTEMS PORTABLE OXYGEN GENERATOR SYSTEM". The FDA issued a decision of Substantially Equivalent on January 8, 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
- January 8, 2002
- Date Received
- December 11, 2001
- 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