510(k) K072469
K072469 is an FDA 510(k) premarket notification submitted by Digiflo, Inc. for the device "DIGIFLO CONCENTRATOR ANALYZER". The FDA issued a decision of Substantially Equivalent on January 3, 2008. The device falls under product code CCL (Analyzer, Gas, Oxygen, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1720.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 3, 2008
- Date Received
- September 4, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Analyzer, Gas, Oxygen, Gaseous-Phase
- Device Class
- Class II
- Regulation Number
- 868.1720
- Review Panel
- AN
- Submission Type