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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: RESPeRATE
Classification Name: DEVICE, BIOFEEDBACK
Product Code: HCC
Device Class: 2
Regulation Number: 882.5050
Medical Specialty: Neurology
Registered Establishment Name: 2BREATHE TECHNOLOGIES LTD
Registered Establishment Number: 3013263129
Premarket Submission Number: K020399
Owner/Operator: 2breathe technologies LTD
Owner/Operator Number: 10052413
Establishment Operations: Specification Developer
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