510(k) K875183
K875183 is an FDA 510(k) premarket notification submitted by Ametek/Thermox Instruments Division for the device "LC OXYGEN ANALYZER". The FDA issued a decision of Substantially Equivalent on March 29, 1988. The device falls under product code CCL (Analyzer, Gas, Oxygen, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1720. Ametek/Thermox Instruments Division has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 29, 1988
- Date Received
- December 22, 1987
- 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