COSMED QUARK C12/QUARK T12— 510(k) K014262

Substantially Equivalent

Cosmed Srl

FDA 510(k) clearance K014262 for COSMED QUARK C12/QUARK T12, Substantially Equivalent on 2002-03-26. Applicant: Cosmed Srl.

Clearance details

Applicant: Cosmed Srl
Product code: Code DPS
Advisory panel: Cardiovascular
Date received: 2001-12-27
Decision date: 2002-03-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Cadwell, NJ, US

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Adverse events under product code DPS

product code DPS

Death: 7
Total: 7

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.