510(k) K053407
K053407 is an FDA 510(k) premarket notification submitted by Analytical Industries, Inc. for the device "OXYGEN ANALYZER, MODELS AII 20000A, AII 2000HC, AII 2000M". The FDA issued a decision of Substantially Equivalent on April 5, 2006. The device falls under product code CCL (Analyzer, Gas, Oxygen, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1720. Analytical Industries, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 5, 2006
- Date Received
- December 7, 2005
- 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