OCCObaby

Bundle of two thermometers: OCCOscan - The Non-contact Infrared Thermometer uses infrared sensor (thermopile) to detect the radiated infrared energy emitted by the object, solid, liquid or…

Registry build 21.09.26

Bundle of two thermometers: OCCOscan – The Non-contact Infrared Thermometer uses infrared sensor (thermopile) to detect the radiated infrared energy emitted by the object, solid, liquid or gas. The intensity of the emitted energy depends on the temperature of the object and the infrared sensor can recognize it to transfer to the proper electronic signal. The electronic signal can be processed in the subject device to convert to the temperature reading. Therefore, the subject device is able to measure the temperature of a person by the energy the person emits. OCCOflex – Digital Thermometer enables fast and reliable measurements. These thermometers provide very high clinical accuracy and have been designed to provide maximum user-friendliness. Digital Thermometer series can be used in conjunction with or without a disposable probe cover when preferred. The basic principle of these thermometers is that a change of thermistor resistance, caused by changes in temperature, is converted to changes of frequency of R-C oscillator circuit. Therefore, the temperature can be given by measuring the frequency of the oscillator. For a given time period by applying to R-C oscillator circuit, changes of temperature will correspond to changes of pulse number.

115manufacturers in China registered for this device type
4catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (68), Zhejiang (15), Jiangsu (13). 17 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code FLL
Manufacturer City Province Registered as Device types
Amphenol Medical Technologies (Dongguan) Co., Ltd. Dongguan Guangdong Contract manufacturer 77
Well Lead Medical Co., Ltd. Guangzhou Guangdong Contract manufacturer 46
Zhejiang Hongyu Medical Commodity Co., Ltd. Yiwu Zhejiang Contract manufacturer 36
Hochuen Medical Technology Co., Ltd. Shenzhen Guangdong Contract manufacturer 20
Jiangyin Sinbon Electronics Co Ltd Jiangyin Jiangsu Contract manufacturer 13
Tianjin Choice Medical Device Co., Ltd. Tianjin Tianjin Contract manufacturer 12
Medwell Technology Limited Dongguan Guangdong Contract manufacturer 10
Famidoc Technology Co., Ltd. Dong Guan Guangdong Contract manufacturer 9
EMI (Dongguan) Asia Limited Dongguan Guangdong Contract manufacturer 9
Tasco Medical Industries Co., Ltd. Bao An District, Shenzhen Guangdong Contract manufacturer 6
Wuhan Strong Electronics Wuhan Hubei Contract manufacturer 6
Betacera Inc. Suzhou Jiangsu Contract manufacturer 3

Showing 12 of 115. All 115 manufacturers in China registered for Continuous Measurement Thermometer

Record

Regulatory record for OCCObaby
Listed by Deocco LLC
FDA product code FLL
Device type Continuous Measurement Thermometer
Device class Class 2
Regulation 21 CFR 880.2910
510(k) K131243
Record published 2016-09-23
Record revised 2021-10-18 (version 5)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Over the counter Yes
Label carries lot or batch number
Packaging Inner carton of 10, carton of 50, master carton of 15, carton of 150, shipping carton of 300, master case of 150
Distribution end date 2020-04-30

Catalogue Numbers

Catalogue numbers for OCCObaby
Catalogue number Size Status
OCCOflex 43 In distribution
OCCOflex In distribution
OCCOscan OCCOflex Bundle Withdrawn
OCCOscan Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Unimed Unimed Medical Supplies Inc 434
Safety 1st Dorel Juvenile Group, Inc. 180
Welch Allyn, Inc. Welch Allyn, Inc. 66
Diagnostix™ American Diagnostic Corp. 61
DeRoyal Deroyal Industries, Inc. 58
Braun KAZ USA, Inc. 53
Exergen Temporal Scanner Exergen Corporation 50
Level 1 ICU Medical, Inc 48
Famidoc Famidoc Technology Co., Ltd. 47
Adtemp™ American Diagnostic Corp. 35
TempTraq Blue Spark Technologies, Inc. 35
Medline Medline Industries, Inc. 34

Showing 12 of 843. All products under Continuous Measurement Thermometer

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer