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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: 989803179541 Mobile CL Respiration Pod Attachment; IntelliVue CL Respiration Pod, SW Rev. B.0; IntelliVue GuardianSoftware SW Rev. A.02; IntelliVue Multi-Measurement Module X2, SW Rev. J.07; IntelliVue Patient Monitor MP2, SW Rev. J.07; IntelliVue Patient Monitor MP5, MP5T, MP5SC, SW Rev. J.07
Classification Name: MONITOR, BREATHING FREQUENCY
Product Code: BZQ
Device Class: 2
Regulation Number: 868.2375
Medical Specialty: Anesthesiology
Registered Establishment Name: Philips North America LLC
Registered Establishment Number: 1218950
Premarket Submission Number: K122223
Owner/Operator: Philips Medical Systems International BV
Owner/Operator Number: 1217116
Establishment Operations: Complaint File Establishment
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