DIGITAL THERMOMETER CLASSIC TYPE AND FLEXIBLE TYPE— 510(k) K023711

Substantially Equivalent

Acute Ideas Co. , Ltd.

FDA 510(k) clearance K023711 for DIGITAL THERMOMETER CLASSIC TYPE AND FLEXIBLE TYPE, Substantially Equivalent on 2002-11-21. Applicant: Acute Ideas Co. , Ltd.. Device class: 2.

Clearance details

Applicant
Acute Ideas Co. , Ltd.
Product code
Code FLL
Device class
Class 2
Regulation
21 CFR 880.2910
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Taipei, TW
Download summary PDFView on FDA.gov ↗

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Adverse events under product code FLL

product code FLL
Death
3
Malfunction
557
Total
560

Source: openFDA MAUDE database, through . 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.