DIGITAL CLINICAL THERMOMETER, MODEL ACT 3020— 510(k) K021614
Substantially EquivalentActherm, Inc.
FDA 510(k) clearance K021614 for DIGITAL CLINICAL THERMOMETER, MODEL ACT 3020, Substantially Equivalent on 2002-05-30. Applicant: Actherm, Inc.. Device class: 2.
Clearance details
- Applicant
- Actherm, Inc.
- 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
- Special
- Location
- Hsinchu, TW
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More clearances from Actherm, Inc.
view all- K093795 — ACTHERM INFRARED EAR THERMOMETER ACT 8000R SERIES AND ITS PROBE COVER MED ACCU2010
- K083419 — ACTHERM DIGITAL CLINICAL THERMOMETER PROBE COVERS, MODEL(S) MEDACCU1010, MEDACCU1010-1, MEDACCU1020
- K090031 — ACTHERM INFRARED EAR THERMOMETER, ACT 8000 SERIES; PROBE COVER FOR ACTHERM INFRARED EAR THERMOMETER, MODEL MEDACCU2010
- K070028 — CLASSIC/HYPOTHERMIA, FLEXIBLE, 10-SECOND, LEFT-RIGHT HANDED, BASAL, LIGHTWEIGHT-PROBE DIGITAL CLINICAL THERMOMETER
- K031905 — DIGITAL CLINICAL THERMOMETER, MODELS ACT2130, ACT 2230, ACT 2330, ACT 3136, AND ACT 3030
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.