DIGITAL CLINICAL THERMOMETER MODEL V901US— 510(k) K112116

Substantially Equivalent

Amperor-Electronic(Sz) Co., Ltd.

FDA 510(k) clearance K112116 for DIGITAL CLINICAL THERMOMETER MODEL V901US, Substantially Equivalent on 2011-10-04. Applicant: Amperor-Electronic(Sz) Co., Ltd..

Clearance details

Applicant: Amperor-Electronic(Sz) Co., Ltd.
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2011-07-25
Decision date: 2011-10-04
Decision: Substantially Equivalent
Clearance type: Special
Location: Southborough, MA, 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.