EXACON TEMP. PROBES SYSTEM 8000-#TH-103— 510(k) K821556

Substantially Equivalent

Sat Export Engineering & Trading

FDA 510(k) clearance K821556 for EXACON TEMP. PROBES SYSTEM 8000-#TH-103, Substantially Equivalent on 1982-08-16. Applicant: Sat Export Engineering & Trading.

Clearance details

Applicant: Sat Export Engineering & Trading
Product code: Code FLL
Advisory panel: General Hospital
Date received: 1982-05-25
Decision date: 1982-08-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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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.