QTMICRO(TM) SYSTEM— 510(k) K950305

Name: FDA 510(k) clearance K950305
Creator: U.S. Food and Drug Administration
Published: 1995-10-13

Substantially Equivalent

Q.I. Medical, Inc.

FDA 510(k) clearance K950305 for QTMICRO(TM) SYSTEM, Substantially Equivalent on 1995-10-13. Applicant: Q.I. Medical, Inc.. Device class: 2.

Clearance details

Applicant: Q.I. Medical, Inc.
Product code: Code LHI
Device class: Class 2
Regulation: 21 CFR 880.5440
Advisory panel: General Hospital
Date received: 1995-01-25
Decision date: 1995-10-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nevada City, CA, 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.