510(k) K904163
K904163 is an FDA 510(k) premarket notification submitted by Norco, Inc. for the device "CLINICAL BLOOD GAS MIXTURES". The FDA issued a decision of Substantially Equivalent on November 1, 1990. The device falls under product code LCH (Tonometer (Calibration And Q.C. Of Blood-Gas Instruments), Clinical), a Class I device regulated under 21 CFR 862.1660. Norco, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 1, 1990
- Date Received
- September 11, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tonometer (Calibration And Q.C. Of Blood-Gas Instruments), Clinical
- Device Class
- Class I
- Regulation Number
- 862.1660
- Review Panel
- CH
- Submission Type