510(k) K121167
K121167 is an FDA 510(k) premarket notification submitted by Caire, Inc. for the device "CAIRE COMPANION 5 OXYGEN CONCENTRATOR". The FDA issued a decision of Substantially Equivalent on May 2, 2012. The device falls under product code CAW (Generator, Oxygen, Portable), a Class II device regulated under 21 CFR 868.5440. Caire, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 2, 2012
- Date Received
- April 17, 2012
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Generator, Oxygen, Portable
- Device Class
- Class II
- Regulation Number
- 868.5440
- Review Panel
- AN
- Submission Type