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510(k) Data Aggregation
K Number
K172141Device Name
Pulse Oximeter
Manufacturer
Shanghai Berry Electronic Tech Co., Ltd
Date Cleared
2018-04-04
(261 days)
Product Code
DQA
Regulation Number
870.2700Why did this record match?
Applicant Name (Manufacturer) :
Shanghai Berry Electronic Tech Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The pulse oximeter (BM1000 & BM1000C) is designed for spot checking of the functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult in clinic environment. This medical device can be reused. Not for continuously monitoring.
Device Description
The proposed device, pulse oximeter, includes two models in this application, BM1000C. The two proposed devices all are fingertip device; they are share the following same features:
- Spot check and display SpO2 and PR value;
- Low battery capacity indicator;
- Finger off indicator;
- wireless connection function
Beside the features above, the BM1000 can display Plethysmogram wave, but the BM1000C deoesn't have this function.
The pulse oximeter (BM1000 & BM1000C) is designed for spot checking of thefunctional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult in clinic environment. This medical device can be reused. Not for continuously monitoring.
The proposed device is not provided sterile and is not a reprocessed single-use device.
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K Number
K142687Device Name
Pulse Oximeter
Manufacturer
Shanghai Berry Electronic Tech Co., Ltd
Date Cleared
2015-04-13
(203 days)
Product Code
DQA
Regulation Number
870.2700Why did this record match?
Applicant Name (Manufacturer) :
Shanghai Berry Electronic Tech Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The pulse oximeter (BM1000A & BM2000A) is designed for spot checking of the pulse oxygen saturation and pulse rate for adult in clinic environment. This medical device can be reused. Not for continuously monitoring.
Device Description
The proposed device, pulse oximeter, includes two models in this application, BM1000A and BM2000A. The two proposed devices all are handheld device with detachable SpO2 sensor, the BM1000A work with the SpO2 sensor BSA09001P and the BM2000A work with the SpO2 sensor BST09001S; they share the following same features:
★ Spot check and display SpO2 and PR value;
★ Low battery capacity indicator;
★ Finger off indicator;
The pulse oximeter (BM1000A & BM2000A) is designed for spot checking of the pulse oxygen saturation and pulse rate for adult in clinic environment. This medical device can be reused. Not for continuously monitoring.
The proposed device is not provided sterile and is not a reprocessed single-use device.
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