740 SELECT— 510(k) K140430
Substantially EquivalentCas Medical Systems, Inc.
FDA 510(k) clearance K140430 for 740 SELECT, Substantially Equivalent on 2014-06-13. Applicant: Cas Medical Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Cas Medical Systems, Inc.
- Product code
- Code MWI
- Device class
- Class 2
- Regulation
- 21 CFR 870.2300
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Branford, CT, US
Recent devices under product code MWI
view allMore clearances from Cas Medical Systems, Inc.
view allAdverse events under product code MWI
product code MWI- Death
- 16
- Malfunction
- 963
- Total
- 979
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.