INSPECTRA STO2 TISSUE OXYGENATION MONITOR— 510(k) K061619

Substantially Equivalent

Hutchinson Technology, Inc.

FDA 510(k) clearance K061619 for INSPECTRA STO2 TISSUE OXYGENATION MONITOR, Substantially Equivalent on 2006-07-12. Applicant: Hutchinson Technology, Inc..

Clearance details

Applicant: Hutchinson Technology, Inc.
Product code: Code MUD
Advisory panel: Cardiovascular
Date received: 2006-06-09
Decision date: 2006-07-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hutchinson, MN, US

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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.