510(k) K810571
K810571 is an FDA 510(k) premarket notification submitted by Vickers America Medical Corp. for the device "NEOCARE OXYGEN MONITOR". The FDA issued a decision of Substantially Equivalent on March 11, 1981. The device falls under product code CCL (Analyzer, Gas, Oxygen, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1720. Vickers America Medical Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 11, 1981
- Date Received
- March 3, 1981
- 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