510(k) K081779
K081779 is an FDA 510(k) premarket notification submitted by Respironics, Inc. for the device "GOLOX-93". The FDA issued a decision of Substantially Equivalent on September 19, 2008. The device falls under product code BYJ (Unit, Liquid-Oxygen, Portable), a Class II device regulated under 21 CFR 868.5655. Respironics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 19, 2008
- Date Received
- June 23, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Unit, Liquid-Oxygen, Portable
- Device Class
- Class II
- Regulation Number
- 868.5655
- Review Panel
- AN
- Submission Type