INDICATOR, BIPOLAR TEMPERATURE— 510(k) K782043

Substantially Equivalent

Micronex, Inc.

FDA 510(k) clearance K782043 for INDICATOR, BIPOLAR TEMPERATURE, Substantially Equivalent on 1979-01-17. Applicant: Micronex, Inc..

Clearance details

Applicant: Micronex, Inc.
Product code: Code FLL
Advisory panel: General Hospital
Date received: 1978-12-08
Decision date: 1979-01-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.