Meritrans ECO Reusable Pressure Transducer, Meritrans ECO Domes— 510(k) K221782
Substantially EquivalentMerit Medical Pte. , Ltd.
FDA 510(k) clearance K221782 for Meritrans ECO Reusable Pressure Transducer, Meritrans ECO Domes, Substantially Equivalent on 2023-03-17. Applicant: Merit Medical Pte. , Ltd.. Device class: 2.
Clearance details
- Applicant
- Merit Medical Pte. , Ltd.
- Product code
- Code DRS
- Device class
- Class 2
- Regulation
- 21 CFR 870.2850
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Singapore, SG
Recent devices under product code DRS
view all- K254074 — TruPress
- K242909 — FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors
- K172458 — HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit
- K163172 — HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit
- K161408 — Compass Cast and MAP
Adverse events under product code DRS
product code DRS- Death
- 8
- Malfunction
- 776
- Total
- 784
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.