510(k) K160153
K160153 is an FDA 510(k) premarket notification submitted by Radiometer Medical Aps for the device "ABL90 FLEX PLUS". The FDA issued a decision of Substantially Equivalent on November 4, 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. Radiometer Medical Aps has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 4, 2016
- Date Received
- January 22, 2016
- Clearance Type
- Special
- 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