BAIR PAWS TEMPERATURE MANAGEMENT SYSTEM MODEL 850— 510(k) K060865

Substantially Equivalent

Arizant Healthcare, Inc.

FDA 510(k) clearance K060865 for BAIR PAWS TEMPERATURE MANAGEMENT SYSTEM MODEL 850, Substantially Equivalent on 2006-04-24. Applicant: Arizant Healthcare, Inc..

Clearance details

Applicant: Arizant Healthcare, Inc.
Product code: Code DWJ
Advisory panel: Cardiovascular
Date received: 2006-03-30
Decision date: 2006-04-24
Decision: Substantially Equivalent
Clearance type: Special
Location: Eden Prairie, MN, 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.