Search Results
Found 5 results
510(k) Data Aggregation
K Number
K160680Device Name
VisioFocus Mini, VisioFocus Smart
Manufacturer
TECNIMED S.R.L.
Date Cleared
2017-04-19
(405 days)
Product Code
FLL
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
TECNIMED S.R.L.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
VisioFocus SMART and VisioFocus Mini are infrared thermometers intermittent measurement of human body temperature in people of all ages. This thermometer is for a measurement site of forehead.
Device Description
Not Found
Ask a Question
K Number
DEN130019Device Name
ZANZA-CLICK
Manufacturer
TECNIMED S.R.L.
Date Cleared
2014-11-07
(617 days)
Product Code
OSG
Regulation Number
882.5894Why did this record match?
Applicant Name (Manufacturer) :
TECNIMED S.R.L.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Zanza-Click (or Disc-o-Click, or Mini-Click) is indicated for temporarily reducing the swelling and itching caused by mosquito bites.
Device Description
The Zanza-Click (or Disc-o-Click, or Mini-Click) is a hand held device, consisting primarily of housing, a push button (which the user depresses to excite the piezoelectric crystal by means of a spring), a "Piezo unit" (containing piezoelectric crystal) and electrical output terminals (placed flush to the user's skin) intended to deliver electrical current to the skin.
Ask a Question
K Number
K122412Device Name
VISIOFOCUS
Manufacturer
TECNIMED S.R.L.
Date Cleared
2013-03-13
(217 days)
Product Code
FLL
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
TECNIMED S.R.L.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
VisioFocus 06400, 06450, 06480 and 06490 series are infrared thermometers intended for intermittent measurement of human body temperature in people of all ages.
Device Description
Not Found
Ask a Question
K Number
K072108Device Name
MODIFICATION TO THERMOFOCUS 0800, 0900, 01500 AND 0700 SERIES
Manufacturer
TECNIMED S.R.L.
Date Cleared
2007-08-31
(30 days)
Product Code
FLL
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
TECNIMED S.R.L.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Thermofocus 0800, 0900, 01500, 0700 Series are infrared thermometers intended for the intermittent measurement of human body temperature in people of all ages.
Device Description
Thermofocus devices belonging to the 0800, 0900, 01500, 0700 series are hand-held and battery-operated thermometers. They take skin temperature mainly in the middle of the forehead, on the navel, neck or under the armpit. The Thermofocus devices use the principle of surveying the natural emission of infrared thermal radiation from all objects, including the human body. Thermofocus thermometers take temperature at distance, without any contact with the patient.
Ask a Question
K Number
K033790Device Name
THERMOFOCUS 0800, 0900, 01500 AND 0700 SERIES
Manufacturer
TECNIMED S.R.L.
Date Cleared
2004-06-03
(182 days)
Product Code
FLL
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
TECNIMED S.R.L.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Thermotocus series 0800, 01500 and 0700 are infrared thermometers intended for the intermittent measurement of human body temperature of people of all ages
Device Description
Thermofocus devices belonging to the 0800, 0900, 01500, 0700 series are hand-held and battery-operated, taking skin temperature mainly in the middle of the forehead. In case of difficult to take the temperature on this area it is also possible to take the temperature on the navel or under the armpit. The Thermofocus devices use the principle of surveying the natural emission of infrared thermal radiation from all objects, including the human body. Thanks to an exclusive optic aiming system, the peculiarity of Thermofocus thermometers is to take the temperature at distance, without any contact with the patient.
Ask a Question
Page 1 of 1