T-STAT 303 ISCHEMIA MONITORING SYSTEM— 510(k) K081233

Substantially Equivalent

Spectros Corporation

FDA 510(k) clearance K081233 for T-STAT 303 ISCHEMIA MONITORING SYSTEM, Substantially Equivalent on 2008-07-28. Applicant: Spectros Corporation.

Clearance details

Applicant: Spectros Corporation
Product code: Code MUD
Advisory panel: Cardiovascular
Date received: 2008-05-01
Decision date: 2008-07-28
Decision: Substantially Equivalent
Clearance type: Special
Location: Highlands Ranch, CO, 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.