(MT-27) THERMOMETER AND (M-10PC) PROBE COVERS— 510(k) K862333

Substantially Equivalent

Sharp Electronics Corp.

FDA 510(k) clearance K862333 for (MT-27) THERMOMETER AND (M-10PC) PROBE COVERS, Substantially Equivalent on 1986-07-08. Applicant: Sharp Electronics Corp..

Clearance details

Applicant: Sharp Electronics Corp.
Product code: Code FLL
Advisory panel: General Hospital
Date received: 1986-06-19
Decision date: 1986-07-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mahwah, NJ, 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.