PULSE OXIMETER SENSOR (DISPOSABLE AND REUSABLE) MODEL RSA002DN, RSJ002DA, RSJ091DI, RST063CA

Oximeter

BEIJING RONGRUI-CENTURY SCIE. & TECH. CO., LTD.

The following data is part of a premarket notification filed by Beijing Rongrui-century Scie. & Tech. Co., Ltd. with the FDA for Pulse Oximeter Sensor (disposable And Reusable) Model Rsa002dn, Rsj002da, Rsj091di, Rst063ca.

Pre-market Notification Details

• Device ID: K103685
• 510k Number: K103685
• Device Name: PULSE OXIMETER SENSOR (DISPOSABLE AND REUSABLE) MODEL RSA002DN, RSJ002DA, RSJ091DI, RST063CA
• Classification: Oximeter
• Applicant: BEIJING RONGRUI-CENTURY SCIE. & TECH. CO., LTD. P.O. BOX 237-023 Shangahi, CN 200237
• Contact: Diana Hong
• Correspondent: Diana Hong; BEIJING RONGRUI-CENTURY SCIE. & TECH. CO., LTD. P.O. BOX 237-023 Shangahi, CN 200237
• Product Code: DQA
• CFR Regulation Number: 870.2700 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-12-17
• Decision Date: 2011-07-15
• Summary: summary

NIH GUDID Devices

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