510(k) K860808
K860808 is an FDA 510(k) premarket notification submitted by Orange Medical Instruments, Inc. for the device "CONTINUCATH". The FDA issued a decision of Substantially Equivalent on March 13, 1986. The device falls under product code CCE (Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling), a Class II device regulated under 21 CFR 868.1200. Orange Medical Instruments, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 13, 1986
- Date Received
- March 4, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling
- Device Class
- Class II
- Regulation Number
- 868.1200
- Review Panel
- AN
- Submission Type