510(k) K780448
K780448 is an FDA 510(k) premarket notification submitted by Taylor Instrument Analytics Co. for the device "TRANSPORTABLE OXYGEN PURITY ANALYZER". The FDA issued a decision of Substantially Equivalent on April 19, 1978. The device falls under product code CCL (Analyzer, Gas, Oxygen, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1720. Taylor Instrument Analytics Co. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 19, 1978
- Date Received
- March 20, 1978
- 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