510(k) K002382
K002382 is an FDA 510(k) premarket notification submitted by Analytical Industries, Inc. for the device "'ALL 2000' % OXYGEN ANALYZER". The FDA issued a decision of Substantially Equivalent on March 14, 2001. 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
- March 14, 2001
- Date Received
- August 4, 2000
- 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