FDA.reportPublic FDA data

KenTeK

Primary DI
00810003751171
Brand
KenTeK
Company
KENTRON HEALTHCARE, INC.
Model
KT-2000
Catalog number
KT-2000
Device description
KenTeK FINGER PULSE OXIMETER WITH OLED SCREEN, MEASURE BLOOD OXYGEN SATURATION LEVEL AND PULSE RATE, PR WAVEFORM DISPLAY, LOW BATTERY INDICATOR, AUTOMATIC POWER OFF, FOUR DIRECTIONS DISPLAY.
Published
2018-11-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQAOximeter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQAOximeterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141105000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141105000PULSE OXIMETERHunan Accurate Bio-Medical Technology Co., Ltd.2014-12-04DQA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810003751171PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810003751171008100037511718100037511710810003751171

GMDN Terms#

Term, Definition table
TermDefinition
Pulse oximeter, battery-poweredA portable, battery-powered, photoelectric device intended for the transcutaneous measurement and display of haemoglobin oxygen saturation (SpO2). The signals, typically produced by light-emitting diodes (LEDs) and a receiving detector in a probe, or directly built-in, are used to make the measurements using the principle of spectrophotometry. The oximeter displays the SpO2 values and may calculate/display other parameters, e.g., pulse rate, electrocardiogram (ECG). The device is typically applied to the fingertip or around the wrist; it may be used by healthcare facilities, emergency services, or in the home.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
615-384-0573KENTRON@KENTRONMEDICAL.COM

Regulatory Flags#

DUNS number
618825723
Device count
1
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810003750822KENTRON7599252026-06-08
00810003750839KENTRON7599302026-06-08
00810003750846KENTRON7599352026-06-08
00810003750853ENTRON7599402026-06-08
00810003750860KENTRON7599452026-06-08
00810003750877KENTRON7599502026-06-08
00810003750884KENTRON7599552026-06-08
00810003750891KENTRON7599602026-06-08
00810003750907KENTRON7599652026-06-08
00810003750709KENTRON7699502026-06-07
00810003750716KENTRON7699552026-06-07
00810003750723KENTRON7699602026-06-07
00810003750730KENTRON7699652026-06-07
00810003750747KENTRON7699702026-06-07
00810003750754KENTRON7699752026-06-07
00810003750761KENTRON7699802026-06-07
00810003750778KENTRON7699852026-06-07
00810003750785KENTRON7699902026-06-07
00810003750792KENTRON7699952026-06-07
00810003750808KENTRON7691002026-06-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048675785910Masimo SpO2 Module for Vista 300/SShanghai Draeger Medical Instrument Co.,Ltd.DQA2026-07-13
00010939962218N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
00093351041099N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
00845717013550N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
00845717013567N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
06972040113849N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
06972040113856N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
06931973400563CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973400730CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973400785CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410326CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410333CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410340CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
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06931973410371CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
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06931973410432CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
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06931973410678CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410685CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410692CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410715CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410722CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410739CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09