MEDI-THERM (MTA-5900) & DETACHABLE HOSES— 510(k) K912051

Substantially Equivalent

Gaymar Industries, Inc.

FDA 510(k) clearance K912051 for MEDI-THERM (MTA-5900) & DETACHABLE HOSES, Substantially Equivalent on 1991-07-30. Applicant: Gaymar Industries, Inc..

Clearance details

Applicant: Gaymar Industries, Inc.
Product code: Code DWJ
Advisory panel: Cardiovascular
Date received: 1991-05-09
Decision date: 1991-07-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orchard Park, NY, US

Download summary PDF View on FDA.gov ↗

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.