510(k) K840102
K840102 is an FDA 510(k) premarket notification submitted by M. D. Software, Inc. for the device "ARTERIAL BLOOD GAS INTERPRETATION PROG". The FDA issued a decision of Substantially Equivalent on February 4, 1984. 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.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 4, 1984
- Date Received
- January 10, 1984
- 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