510(k) K001095
K001095 is an FDA 510(k) premarket notification submitted by Teledyne Analytical Instruments for the device "OXYGEN SENSORS, MODELS CIR, C2R, R13, R15, RI7MED, R22MED, R23, R24MED, R29MED, T1, T2,T4, T7 & UFO130". The FDA issued a decision of Substantially Equivalent on June 30, 2000. The device falls under product code CCL (Analyzer, Gas, Oxygen, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1720. Teledyne Analytical Instruments has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 30, 2000
- Date Received
- April 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