MEDI-THERM HYPER/HYPOTHERMIA SYSTEM, MODELS MTA6900, MTA7900— 510(k) K100585

Substantially Equivalent

Gaymar Industries, Inc.

FDA 510(k) clearance K100585 for MEDI-THERM HYPER/HYPOTHERMIA SYSTEM, MODELS MTA6900, MTA7900, Substantially Equivalent on 2011-01-20. Applicant: Gaymar Industries, Inc..

Clearance details

Applicant: Gaymar Industries, Inc.
Product code: Code DWJ
Advisory panel: Cardiovascular
Date received: 2010-03-02
Decision date: 2011-01-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orchard Park, NY, US

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Adverse events under product code DWJ

product code DWJ

Death: 7
Injury: 679
Malfunction: 17,477
Total: 18,163

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.