510(k) K071461
K071461 is an FDA 510(k) premarket notification submitted by Copd Partners, Inc. for the device "MODEL 300D HOME OXYGEN LIQUEFIER". The FDA issued a decision of Substantially Equivalent on August 21, 2007. The device falls under product code CAW (Generator, Oxygen, Portable), a Class II device regulated under 21 CFR 868.5440. Copd Partners, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 21, 2007
- Date Received
- May 25, 2007
- 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