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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: Oximeter
Classification Name: OXIMETER
Product Code: DQA
Device Class: 2
Regulation Number: 870.2700
Medical Specialty: Cardiovascular
Registered Establishment Name: 3B Medical Inc
Registered Establishment Number: 3009096682
Premarket Submission Number: K082641
Owner/Operator: React Health
Owner/Operator Number: 10040143
Establishment Operations: Complaint File Establishment
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