K161800

Substantially Equivalent

OnSite-IV

Applicant: Pharmc, LLC
Product code: LHI
Advisory panel: General Hospital
Date received: 2016-06-30
Decision date: 2016-12-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jackson, WY, US

Adverse events under product code LHI

product code LHI

Injury: 207
Malfunction: 7,820
Other: 3
Total: 8,030

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.