510(k) K830446
K830446 is an FDA 510(k) premarket notification submitted by Airco/Ohio Medical Products for the device "OXYGEN MONITOR OHIO 5100". The FDA issued a decision of Substantially Equivalent on March 24, 1983. The device falls under product code CCL (Analyzer, Gas, Oxygen, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1720. Airco/Ohio Medical Products has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 24, 1983
- Date Received
- February 10, 1983
- 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