Integrated CardioRespiratory System— 510(k) K173156
Substantially EquivalentSensydia, Inc.
FDA 510(k) clearance K173156 for Integrated CardioRespiratory System, Substantially Equivalent on 2018-06-08. Applicant: Sensydia, Inc..
Clearance details
- Applicant
- Sensydia, Inc.
- Product code
- Code MWJ
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Los Angeles, CA, US
Adverse events under product code MWJ
product code MWJ- Other
- 1
- Total
- 1
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.