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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: EasyOne Pro/Pro LAB
Classification Name: CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION
Product Code: BTY
Device Class: 2
Regulation Number: 868.1890
Medical Specialty: Anesthesiology
Registered Establishment Name: ZOLLNER ELECTRONICS GMBH
Registered Establishment Number: 3010594620
Premarket Submission Number: K161534
Owner/Operator: Zollner Electronics GmbH
Owner/Operator Number: 10045311
Establishment Operations: Contract Manufacturer
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