Pulse Oximeter Sensor (disposable And Reusable) (Rsa002dn +3 more)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K103685

by Beijing Rongrui-Century Scie. & Tech. Co., Ltd.

Identifiers

510(k) Number: K103685 FDA 510(k)
FDA Product Code: DQA FDA 510(k)
Models / Variants: Rsa002dn FDA 510(k)
Rsj002da FDA 510(k)
Rsj091di FDA 510(k)
Rst063ca FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 870.2700 FDA 510(k)
Regulation Number: 870.2700 FDA 510(k)
Advisory Committee: Cardiovascular FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

Pulse Oximeter Sensor (disposable And Reusable) (Rsa002dn +3 more) by Beijing Rongrui-Century Scie. & Tech. Co., Ltd. — Class II — FDA_510K — listed in FDA…

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K103685	Class II	Active

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Manufacturer

Manufacturer: Beijing Rongrui-Century Scie. & Tech. Co., Ltd.

Sources (1)

FDA 510(k) K103685 24 fields · synced Jun 18, 2026