INPECTRA STO2 SPOT CHECK— 510(k) K103613

Name: FDA 510(k) clearance K103613
Creator: U.S. Food and Drug Administration
Published: 2011-03-02

Substantially Equivalent

Hutchinson Technology, Inc.

FDA 510(k) clearance K103613 for INPECTRA STO2 SPOT CHECK, Substantially Equivalent on 2011-03-02. Applicant: Hutchinson Technology, Inc.. Device class: 2.

Clearance details

Applicant: Hutchinson Technology, Inc.
Product code: Product code MUD
Device class: Class 2
Regulation: 21 CFR 870.2700
Advisory panel: Cardiovascular
Date received: 2010-12-09
Decision date: 2011-03-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hutchinson, MN, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code MUD

product code MUD

Malfunction: 467
Total: 467

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.