HCT Empty EVA Container Pack— 510(k) K190328
Substantially EquivalentHealth Care Technologies
FDA 510(k) clearance K190328 for HCT Empty EVA Container Pack, Substantially Equivalent on 2019-08-15. Applicant: Health Care Technologies.
Clearance details
- Applicant
- Health Care Technologies
- Product code
- Code KPE
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ashland, MA, US
Adverse events under product code KPE
product code KPE- Malfunction
- 1,000
- Other
- 1
- Total
- 1,001
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.