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510(k) Data Aggregation
K Number
K103685Device Name
PULSE OXIMETER SENSOR (DISPOSABLE AND REUSABLE) MODEL RSA002DN, RSJ002DA, RSJ091DI, RST063CA
Manufacturer
Date Cleared
2011-07-15
(210 days)
Product Code
Regulation Number
870.2700Why did this record match?
Applicant Name (Manufacturer) :
**BEIJING RONGRUI-CENTURY SCIE. **& TECH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Disposable Pulse Oximeter Sensor is indicated for non-invasive spot checking and/or continuous monitoring of arterial oxygen saturation and pulse rate of the adult or neonatal patients with oximeter equipment in hospitals, hospital-type facilities, and home care environments.
The Reusable Pulse Oximeter Sensors are indicated for non-invasive spot checking and/or continuous monitoring of arterial oxygen saturation and pulse rate of the adult or pediatric patients with oximeter equipment in hospitals, hospital-type facilities, and home care environments.
Device Description
The proposed devices of the Pulse Oximeter Sensors (Disposable and Reusable), are used in conjunction with oximeter equipment to measure and display the arterial oxygen saturation of blood.
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