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510(k) K162014

Device
Nellcor Flexible SpO2 Sensor, Nellcor Flexible SpO2 Sensor, Small, Nellcor Flexible SpO2 Sensor, Home Care (same Sensor As Above, Home Use Guide Incl.), Nellcor Flexible SpO2 Sensor, Small, Home Care (same Sensor As Above, Home Use Guide Incl.)
Applicant
BLUEPOINT MEDICAL GMBH & CO. KG
510(k) number
K162014
Product code
DQA  
Decision
Substantially Equivalent (SESE)
Decision date
2017-02-06
Date received
2016-07-21
Regulation
870.2700
Classification name
Oximeter
Medical specialty
Cardiovascular
Review panel
Anesthesiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
BERND LINDNER
Address
An Der Trave 15 Selmsdorf DE 23923 23923

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DQA  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K252821Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)Philips Medizin Systeme Böblingen GmbH2026-05-29
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

Legacy Summary#

summary

FDA Review#

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