510(k) K052396
K052396 is an FDA 510(k) premarket notification submitted by Oxysure Systems, Inc. for the device "OXYSURE PORTABLE OXYGEN GENERATOR, MODEL 615". The FDA issued a decision of Substantially Equivalent on December 9, 2005. The device falls under product code CAW (Generator, Oxygen, Portable), a Class II device regulated under 21 CFR 868.5440.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 9, 2005
- Date Received
- August 31, 2005
- 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