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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: CompuRecord System
Classification Name: GAS-MACHINE, ANESTHESIA
Product Code: BSZ
Device Class: 2
Regulation Number: 868.5160
Medical Specialty: Anesthesiology
Registered Establishment Name: Philips North America LLC
Registered Establishment Number: 1218950
Premarket Submission Number: K083413
Owner/Operator: Philips Medical Systems International BV
Owner/Operator Number: 1217116
Establishment Operations: Complaint File Establishment
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