510(k) K100777
K100777 is an FDA 510(k) premarket notification submitted by Radiometer Medical Aps for the device "ABL837 FLEX ANALYZER". The FDA issued a decision of Substantially Equivalent on December 10, 2010. 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
- December 10, 2010
- Date Received
- March 18, 2010
- Clearance Type
- Abbreviated
- 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