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510(k) K201887

Device
VS Newborn Heart Rate Monitor
Applicant
SurePulse Medical Limited
510(k) number
K201887
Product code
DQA  
Decision
Substantially Equivalent (SESE)
Decision date
2021-07-23
Date received
2020-07-08
Regulation
870.2700
Classification name
Oximeter
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
James Carpenter
Address
Medicity, D6 Thane Rd. Nottingham GB NG90 gbh NG90 gbh

FDA Registration Numbers

Source Documents

510(k) summary PDF

Related GUDID Devices

Primary DIBrandCompanyPublished
05060550650075VS SystemSUREPULSE MEDICAL LIMITED2025-06-26
05060550650044VS Cap Extra LargeSUREPULSE MEDICAL LIMITED2025-06-26
05060550650037VS Cap LargeSUREPULSE MEDICAL LIMITED2025-06-26
05060550650020VS Cap MediumSUREPULSE MEDICAL LIMITED2025-06-26
05060550650013VS Cap SmallSUREPULSE MEDICAL LIMITED2025-06-26
05060550650006VS Cap Extra SmallSUREPULSE MEDICAL LIMITED2025-06-26

Other 510(k) Records For Product Code DQA  

510(k)DeviceApplicantDecision date
K252655Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT)Shenzhen Imdk Medical Technology Co., Ltd.2026-05-11
K253887Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor (989803205401)Philips Medizin Systeme2026-05-01
K260931Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)Unimed Medical Supplies, Inc.2026-04-14
K252448AViTA Pulse Oximeter (SP61)Avita Corporation2026-02-27
K252805YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.2026-02-17
K253109Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O)Shenzhen Best Electronics Co., Ltd.2026-01-07
K251751Spo2 Sensor CSS032DShenzhen Ykd Technology Co., Ltd.2025-12-19
K251696Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48); Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-29)Unimed Medical Supplies, Inc.2025-12-01
K251691Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U203S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U103S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U103-08)Unimed Medical Supplies, Inc.2025-12-01
K251695Unimed Reusable SpO2 Sensors (-06 Series) (U403S-06); Unimed Reusable SpO2 Sensors (-06 Series) (U203S-06); Unimed Reusable SpO2 Sensors (-06 Series) (U103S-06)Unimed Medical Supplies, Inc.2025-11-18
K251693Unimed Reusable SpO2 Sensors (-75 Series) (U410-75); Unimed Reusable SpO2 Sensors (-75 Series) (U110-75); Unimed Reusable SpO2 Sensors (-75 Series) (U410S-75); Unimed Reusable SpO2 Sensors (-75 Series) (U110S-75); Unimed Reusable SpO2 Sensors (-75 Series) (U210S-75)Unimed Medical Supplies, Inc.2025-11-18
K250837Pulse OximeterShanghai Berry Electronic Tech Co., Ltd.2025-09-25
K250931Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U403-117); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U103-117); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U410-121); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U110-121)Unimed Medical Supplies, Inc.2025-08-13
K241086Avidhrt Sense SpO2Avidhrt, Inc.2025-05-09
K242876Pulse Oximeter ( PO2, PO2A, PO2B)Shenzhen Viatom Technology Co., Ltd.2025-02-28

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FDA Review

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