510(k) K050153
K050153 is an FDA 510(k) premarket notification submitted by Caire, Inc. for the device "SPIRIT, MODEL HAS". The FDA issued a decision of Substantially Equivalent on April 15, 2005. The device falls under product code BYJ (Unit, Liquid-Oxygen, Portable), a Class II device regulated under 21 CFR 868.5655. Caire, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 15, 2005
- Date Received
- January 24, 2005
- 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