510(k) K013251
K013251 is an FDA 510(k) premarket notification submitted by Caire, Inc. for the device "SPIRIT 300". The FDA issued a decision of Substantially Equivalent on December 18, 2001. 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
- December 18, 2001
- Date Received
- September 28, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Unit, Liquid-Oxygen, Portable
- Device Class
- Class II
- Regulation Number
- 868.5655
- Review Panel
- AN
- Submission Type