FDA.reportPublic FDA data

SINO-K

Primary DI
06972820960656
Brand
SINO-K
Company
Shenzhen SINO-K Medical Technology Co.,Ltd
Model
SP1019
Device description
Disposable SpO2 Sensor
Published
2022-02-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
DQAOximeter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQAOximeterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192608000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192608000Disposable SpO2 SensorShenzhen Sino-K Medical Technology Co.,Ltd2020-01-24DQA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06972820960656PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06972820960656069728209606566972820960656

GMDN Terms#

Term, Definition table
TermDefinition
Pulse oximeter probe, single-useA photoelectric device designed to be applied externally to a body site (e.g., fingertip, ear lobe, bridge of nose, toe, or bridge of the foot) for the transcutaneous measurement of haemoglobin oxygen saturation (SpO2) in arterial blood using signals produced by a light-emitting diode (LED) and received by a photodetector. The signals are subsequently transmitted to an oximeter/monitor (not included) which measures and displays the SpO2. The is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
554477241
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06972820963664SINO-KSG31XXS2022-02-17
06972820963671SINO-KSG31XXP2022-02-17
06972820963688SINO-KSG51XXS2022-02-17
06972820963695SINO-KSG51XXP2022-02-17
06972820963701SINO-KSG32XXS2022-02-17
06972820963718SINO-KSG32XXP2022-02-17
06972820963725SINO-KSG52XXP2022-02-17
06972820963732SINO-KSG52XXS2022-02-17
06972820963749SINO-KSK11XXN2022-02-17
06972820963756SINO-KSK12XXN2022-02-17
06972820963763SINO-KSK12XXB2022-02-17
06972820963770SINO-KSK11XXB2022-02-17
06972820963602SINO-KSC13112023-09-05
06942108005546SINO-KSC01062023-09-05
06942108005553SINO-KSC01072023-09-05
06942108005560SINO-KSC01082023-09-05
06972820961509SINO-KSC01092023-09-05
06972820961516SINO-KSC01102023-09-05
06972820961523SINO-KSC01112023-09-05
06972820961530SINO-KSC01122023-09-05

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
06931973410364CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410371CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410388CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410395CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410401CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410418CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410425CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410432CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410449CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410456CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410647CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
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