HYPERSPECTRAL TISSUE OXYGENATION MEASUREMENT SYSTEM, MODEL OXY VU1— 510(k) K061848

Substantially Equivalent

Hypermed, Inc.

FDA 510(k) clearance K061848 for HYPERSPECTRAL TISSUE OXYGENATION MEASUREMENT SYSTEM, MODEL OXY VU1, Substantially Equivalent on 2006-11-08. Applicant: Hypermed, Inc..

Clearance details

Applicant: Hypermed, Inc.
Product code: Code MUD
Advisory panel: Cardiovascular
Date received: 2006-06-30
Decision date: 2006-11-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Winchester, MA, 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.