510(k) K221900
K221900 is an FDA 510(k) premarket notification submitted by Nova Biomedical Corporation for the device "Stat Profile Prime Plus Analyzer System". The FDA issued a decision of Substantially Equivalent on September 29, 2023. 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. Nova Biomedical Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 29, 2023
- Date Received
- June 30, 2022
- 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