Search Results
Found 8 results
510(k) Data Aggregation
K Number
K093795Device Name
ACTHERM INFRARED EAR THERMOMETER ACT 8000R SERIES AND ITS PROBE COVER MED ACCU2010
Manufacturer
ACTHERM, INC.
Date Cleared
2010-03-12
(92 days)
Product Code
FLL
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
ACTHERM, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Actherm Infrared Ear Thermometers ACT 8000R Series are used to measure body temperature from auditory canal. This device is intended for household and hospital use on pcople of all age, and is used with or without probe cover medACCU2010.
Device Description
Actherm Infrared Ear Thermometers (Model ACT 8000R Series) are electronic thermometers using a thermopile as the temperature sensor. The sensor's electric signal is then calculated and displayed by a Micro-Controller. These thermometers display the temperature decimal. To compare with ACT 8000 Series, Model ACT 8000R Series has the same indication for use. ACT 8000R Series can be made with various functions, such as Dual scale, Backlight, Scan LED, W/O cover, following with the model number indicates scale switchable, with Backlight, with Scan completed indicator, without probe cover, will be added following the model number. The infrared ear thermometer comprises: a thermopile for temperature sensing, a buzzer for sounding effect, a Micro Controller and a LCD display for calculating and displaying the target temperature digitally. Actherm Infrared Ear Thermometers ACT 8000R Series can be combined with accessories, base, wall mount and power adapter. The base is a tray for holding probe cover box, power input, power/charge indicator, portable/ fixed probe-cover dispenser and the area for placing digital thermometer and its probe cover. For the wall mount, it can be fixed on the wall and the base can be put on this wall mount. The system uses two 1.5V DC alkaline rechargeable batteries for the power supply and the battery power is automatically the Micro-Controller and displayed in LCD if the battery is exhausted. The batteries can be recharged only when the ear thermometer ACT8000R put on the base. ACT 8000R cannot be used when recharging.
Ask a Question
K Number
K083419Device Name
ACTHERM DIGITAL CLINICAL THERMOMETER PROBE COVERS, MODEL(S) MEDACCU1010, MEDACCU1010-1, MEDACCU1020
Manufacturer
ACTHERM, INC.
Date Cleared
2009-07-16
(239 days)
Product Code
FLL
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
ACTHERM, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Actherm Digital Clinical Thermometer Probe Covers medACCU1010, medACCU1010-1 and medACCU1020 are accessories for digital thermometers, including the models of Actherm Digital Clinical Thermometers. They are indicated for use as barriers between digital thermometers and users' rectum or oral cavities to avoid the possible contamination and infection during temperature measuring. These probe covers are intended for single use when temperature taking.
Device Description
The Digital Clinical Thermometer Probe Covers medACCU1010 and medACCU1010-1 are manufactured in the same shapes and sizes. The only difference between them is medACCU1010-1 coated with lubrication; therefore it is only used for rectal measurements for digital thermometers. The Digital Clinical Thermometer Probe Covers medACCU1020 are manufactured in different shapes and sizes from medACCU1010 and medACCU1010-1. The disposable digital thermometer probe covers medACCU1010 and medACCU1020 are used for either oral or rectal measurements for digital thermometers.
Ask a Question
K Number
K090031Device Name
ACTHERM INFRARED EAR THERMOMETER, ACT 8000 SERIES; PROBE COVER FOR ACTHERM INFRARED EAR THERMOMETER, MODEL MEDACCU2010
Manufacturer
ACTHERM, INC.
Date Cleared
2009-04-16
(101 days)
Product Code
FLL
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
ACTHERM, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Actherm Infrared Ear Thermometers ACT8000 Series are used to measure body temperature from auditory canal. This device is intended for household and hospital use on people of all age, and is used with or without probe cover medACCU2010.
Device Description
Infrared Ear Thermometers (Model ACT8000 Series) are electronic Actherm thermometers using a thermopile as the temperature sensor's electric signal is then calculated and displayed by a MicroController. These thermometers display the temperature decimal. Model ACT8000 Series has the same indication for use. However, appearance difference exists between ACT8000 Series. Dual scale, Backlight, Scan LED, W/O cover, following with the model number indicates scale switchable, with Backlight, with Scan completed indicator, without probe cover.
The digital thermometer comprises: a thermopile for temperature sensing, a buzzer for sounding effect, a Micro Controller and a LCD display for calculating and displaying the target temperature digitally.
The system uses two 1.5V DC batteries for the power supply and the battery power is automatically checked by the MicroController and displayed in LCD if the battery is exhausted.
Actherm Infrared Ear Thermometers ACT8000 Series can be combined with accessories, weighting base and wall mount. For the weighting base, the whole set of body temperature measurement devices, including infrared ear thermometer, digital thermometer, and probe cover, can be put on it, For the wall mount, it can be fixed on the wall and the cradle of infrared ear thermometer can be put on this wall mount. Also, the probe cover boxes can be hanged on the hook that under the wall mount or put inside the cradle.
Ask a Question
K Number
K070028Device Name
CLASSIC/HYPOTHERMIA, FLEXIBLE, 10-SECOND, LEFT-RIGHT HANDED, BASAL, LIGHTWEIGHT-PROBE DIGITAL CLINICAL THERMOMETER
Manufacturer
ACTHERM, INC.
Date Cleared
2007-02-08
(36 days)
Product Code
FLL
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
ACTHERM, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
All Digital Clinical Thermometers are intended to precisely measure human body temperature. The Thermometers can be used in the measurement of oral, axillary and rectal temperature.
Device Description
The Classic/Hypothermia Digital Clinical Thermometer consists of an electronically sensor which is located in a metal probe and is connected with a PCB and a Liquid Crystal Display all situated in a pen-like plastic housing. This structure is used for all kind of Thermometer mentioned in this description.
Hypothermia Thermometer have a greater measuring range so that they can be used as device for under cooled person temperature monitoring.
A flexible probe tip is provided by the Flexible Digital Clinical Thermometer that makes the measuring of the temperature more comfortable and safer.
With the patented 10-Second Digital Clinical Thermometer every user is able to receive the result of the measurement in a very quick time. The Express Models also operates with the vame efficient reliability and accuracy like the other Thermometer.
Due to a special integrated sensor in the Left-Right Handed Digital Clinical Thermometer display can easily be read whether the Thermometer is held in the right or the left hand. Especially for left-handed people it makes the measuring result read off more pleasant.
The Basal Digital Clinical Thermometer have a fourth digit on the display, because the measurement of this Thermometer is even more accurate compared with normal Thermometer. This precisely measuring method can be used to monitor and interpreting basal temperature changes.
The Lightweight-Probe Digital Clinical Thermometer consists of a flexible probe, connection cord and a display unit embedded in a round housing.
Variants Descriptions: "+" or Hypothermia, Express, Dual scale, Backlight, LR, following with the model numbers indicates different measuring range, different measuring time, scale switchable, with backlight with Left-Right Handed function.
For all Thermometers is essential, that they consist of a temperature sensor embedded in a special designed metal probe, which could be flexible or inelastic. This sensor is connected with the IC unit, which is connected with a Liquid Crystal Display (LCD) to display the measured temperature. All parts are situated in a pen-like plastic housing. During measuring, only the maximum measured value is displayed on LCD window and all devices are non-predictive.
All variant thermometers comply with referenced product standards of ATSM E1112-00, EN12470-3, IEC 60601-1, IEC 60601-1-2 and ISO 10993-1.
Ask a Question
K Number
K031905Device Name
DIGITAL CLINICAL THERMOMETER, MODELS ACT2130, ACT 2230, ACT 2330, ACT 3136, AND ACT 3030
Manufacturer
ACTHERM, INC.
Date Cleared
2003-07-07
(17 days)
Product Code
FLL
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
ACTHERM, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Digital Clinical thermometer, Model ACT2130, ACT 2230, ACT 2330, ACT 3136, ACT 3030's intended use are medical devices, supplied by internal power and intended to precisely measure human body temperature. It can be used in the measurement of oral, axillary and rectal temperature. This is the same intended use as previously cleared for the Actherm Digital Clinical Thermometers, K010238.
Device Description
Not Found
Ask a Question
K Number
K021612Device Name
DIGITAL CLINICAL THERMOMETER, MODELS ACT 2030, 2038
Manufacturer
ACTHERM, INC.
Date Cleared
2002-05-30
(14 days)
Product Code
FLL
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
ACTHERM, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Digital Clinical thermometers, Models ACT 2030 and ACT 2038's intended use are medical devices, supplied by internal power and intended to precisely measure temperature. It can be used in the measurement of oral, axillary and rectal temperature. This is the same intended use as previously cleared for the Actherm Digital Clinical Thermometers, K010238.
Device Description
Digital Clinical Thermometers, Models ACT 2030, ACT 2038
Ask a Question
K Number
K021614Device Name
DIGITAL CLINICAL THERMOMETER, MODEL ACT 3020
Manufacturer
ACTHERM, INC.
Date Cleared
2002-05-30
(14 days)
Product Code
FLL
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
ACTHERM, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Digital Clinical thermometers, Models ACT 3020's intended use are medical devices, supplied by internal power and intended to precisely measure human boduy temperature. It can be used in the measurement of oral, axillary and rectal temperature. This is the same intended use as previously cleared for the Actherm Digital Clinical Thermometers, K010238.
Device Description
Digital Clinical Thermometers, Models ACT 3020
Ask a Question
K Number
K010238Device Name
ACTHERM DIGITAL CLINICAL THERMOMETER, MODELS ACT2000, ACT2010, ACT2000+, ACT2010+, ACT2020+
Manufacturer
ACTHERM, INC.
Date Cleared
2001-02-06
(12 days)
Product Code
FLL
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
ACTHERM, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
Page 1 of 1