Critical Alert CommonPath Enterprise— 510(k) K193043
Substantially EquivalentCritical Alert
FDA 510(k) clearance K193043 for Critical Alert CommonPath Enterprise, Substantially Equivalent on 2020-05-11. Applicant: Critical Alert. Device class: 2.
Clearance details
- Applicant
- Critical Alert
- Product code
- Code MSX
- Device class
- Class 2
- Regulation
- 21 CFR 870.2300
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Jacksonville, FL, US
Recent devices under product code MSX
view allAdverse events under product code MSX
product code MSX- Death
- 59
- Total
- 59
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.