WARM AIR HYPERTHEERMIA SYSTEM (MODELS #130 AND #133)— 510(k) K942790

Substantially Equivalent

Cincinnati Sub-Zero Products, Inc.

FDA 510(k) clearance K942790 for WARM AIR HYPERTHEERMIA SYSTEM (MODELS #130 AND #133), Substantially Equivalent on 1995-01-24. Applicant: Cincinnati Sub-Zero Products, Inc..

Clearance details

Applicant: Cincinnati Sub-Zero Products, Inc.
Product code: Code DWJ
Advisory panel: Cardiovascular
Date received: 1994-06-13
Decision date: 1995-01-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sharonville, OH, 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.