510(k) K884228
K884228 is an FDA 510(k) premarket notification submitted by Cardiovascular Devices, Inc. for the device "CDI(R) 2000 BLOOD GAS MONITOR". The FDA issued a decision of Substantially Equivalent on January 30, 1989. The device falls under product code CBZ (Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling), a Class II device regulated under 21 CFR 868.1170. Cardiovascular Devices, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 30, 1989
- Date Received
- October 7, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling
- Device Class
- Class II
- Regulation Number
- 868.1170
- Review Panel
- AN
- Submission Type