MODIFICATION TO THERMAL ANGEL— 510(k) K012031

Substantially Equivalent

Estill Medical Technologies, Inc.

FDA 510(k) clearance K012031 for MODIFICATION TO THERMAL ANGEL, Substantially Equivalent on 2001-07-26. Applicant: Estill Medical Technologies, Inc..

Clearance details

Applicant: Estill Medical Technologies, Inc.
Product code: Code BSB
Advisory panel: Hematology
Date received: 2001-06-28
Decision date: 2001-07-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Dallas, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code BSB

product code BSB

Death: 5
Malfunction: 1,778
Total: 1,783

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.