OnSite-IV— 510(k) K161800

Name: FDA 510(k) clearance K161800
Creator: U.S. Food and Drug Administration
Published: 2016-12-06

Substantially Equivalent

Pharmc, LLC

FDA 510(k) clearance K161800 for OnSite-IV, Substantially Equivalent on 2016-12-06. Applicant: Pharmc, LLC. Device class: 2.

Clearance details

Applicant: Pharmc, LLC
Product code: Code LHI
Device class: Class 2
Regulation: 21 CFR 880.5440
Advisory panel: General Hospital
Date received: 2016-06-30
Decision date: 2016-12-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jackson, WY, US

Download summary PDF View on FDA.gov ↗

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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.