AOJ AOJ-70D

Device Model:

AOJ-70D

Manufacturer:

Shenzhen AOJ Medical Technology Co. Ltd., 4F + 3F Area A, Building A, Jingfa Industrial Park, Xiawei Yuan, Xixiang Street, Bao'an District, Shenzhen 518101, CHINA.

Measuring functions:

SpO2, Pulse Rate

Primary Client Use:

Intended for self-measurement and home use

Measurement Site:

Finger

Measurement Occurrence:

Single measurements only

Availability:

Available Currently

Description:

The AOJ AOJ-70D is an automatic pulse oximeter. Information regarding the accuracy of its oxygen saturation measurement technology does not appear to be available. Oxygen saturation measurements are taken from the finger. It is intended for self-measurement and home use.

Assessment:

The technology used in the AOJ AOJ-70D, to measure peripheral oxygen saturation, has been declared as being substantially equivalent to that used in another device, according to 510(k), but this is not compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.

Recommendations:

	Accuracy Assessment	Recommendation	Basis
SpO2	FDA (US)	510(k)	510(k) K202173, K232989

Device Family:

AOJ AOJ-70AF, AOJ AOJ-70BF, AOJ AOJ-70CF, AOJ AOJ-70DF, AOJ AOJ-70EF
Legend: F FDA 510(k)