510(k) K160412
K160412 is an FDA 510(k) premarket notification submitted by Instrumentation Laboratory CO for the device "GEM Premier 5000 (Measured Parameters: pH, pCO2 and pO2)". The FDA issued a decision of Substantially Equivalent on December 14, 2016. The device falls under product code CHL (Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph), a Class II device regulated under 21 CFR 862.1120. Instrumentation Laboratory CO has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 14, 2016
- Date Received
- February 12, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
- Device Class
- Class II
- Regulation Number
- 862.1120
- Review Panel
- CH
- Submission Type