510(k) K221782
K221782 is an FDA 510(k) premarket notification submitted by Merit Medical Pte. , Ltd. for the device "Meritrans ECO Reusable Pressure Transducer, Meritrans ECO Domes". The FDA issued a decision of Substantially Equivalent on March 17, 2023. The device falls under product code DRS (Transducer, Blood-Pressure, Extravascular), a Class II device regulated under 21 CFR 870.2850.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 17, 2023
- Date Received
- June 21, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Transducer, Blood-Pressure, Extravascular
- Device Class
- Class II
- Regulation Number
- 870.2850
- Review Panel
- CV
- Submission Type