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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Nuclear Magnetic Resonance Imaging
510(k) Number K203653
Device Name MRI PPG Patient Cable
Applicant
Ivy Biomedical Systems, Inc.
11 Business Park Drive
Branford,  CT  06405
Applicant Contact Alejandra Aceves
Correspondent
Ivy Biomedical Systems, Inc.
11 Business Park Drive
Branford,  CT  06405
Correspondent Contact Alejandra Aceves
Regulation Number892.1000
Classification Product Code
LNH  
Date Received12/15/2020
Decision Date 03/02/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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