ACTHERM INFRARED EAR THERMOMETER ACT 8000R SERIES AND ITS PROBE COVER MED ACCU2010— 510(k) K093795
Substantially EquivalentActherm, Inc.
FDA 510(k) clearance K093795 for ACTHERM INFRARED EAR THERMOMETER ACT 8000R SERIES AND ITS PROBE COVER MED ACCU2010, Substantially Equivalent on 2010-03-12. 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- 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
- K021612 — DIGITAL CLINICAL THERMOMETER, MODELS ACT 2030, 2038
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.