3M SPOTON TEMPERATURE MONITORING SYSTEM— 510(k) K120412

Substantially Equivalent

Arizant Healthcare, Inc.

FDA 510(k) clearance K120412 for 3M SPOTON TEMPERATURE MONITORING SYSTEM, Substantially Equivalent on 2012-05-30. Applicant: Arizant Healthcare, Inc..

Clearance details

Applicant: Arizant Healthcare, Inc.
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2012-02-10
Decision date: 2012-05-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eden Prairie, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FLL

product code FLL

Death: 3
Malfunction: 557
Total: 560

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.