Proprietary Name: |
989803163181 Mobile CL Disposable Small Adult Cuff; 989803163191 Mobile CL Reusable Adult Cuff; 989803163201 Mobile CL Disposable Adult Cuff; 989803163211 Mobile CL Reusable Large Adult Cuff; 989803163221 Mobile CL Disposable Large Adult Cuff; 989803163251 Mobile CL NBP Cradle Kit; 989803168881 Mobile CL Transmitter Cradles; Diverse Specialized Accessories and IntelliVue CL 865220 charging station; IntelliVue CL SpO2 Pod, CL NBP Pod SW Rev. A.0; IntelliVue Multi-Measurement Module X2, SW Rev. H.01; IntelliVue Patient Monitor MP5, MP5T, MP2, SW Rev. H.01; IntelliVue Telemetry System Transceiver TRx4841A, SW Rev. D.0 |
Classification Name: |
DETECTOR AND ALARM, ARRHYTHMIA |
Product Code: |
DSI |
Device Class: |
2 |
Regulation Number: |
870.1025 |
Medical Specialty: |
Cardiovascular |
Registered Establishment Name: |
Philips North America LLC
|
Registered Establishment Number: |
1218950
|
Premarket Submission Number: |
K101600 |
Owner/Operator: |
Philips Medical Systems International BV |
Owner/Operator Number: |
1217116
|
Establishment Operations: |
Specification Developer
|