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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Rebreathing, Radionuclide
510(k) Number K865084
Device Name AMICI XENON REBREATHING SYSTEM*
Applicant
Amici, Inc.
740 Walnut St.
Royersford,  PA  19468
Applicant Contact MICHAEL BONO
Correspondent
Amici, Inc.
740 Walnut St.
Royersford,  PA  19468
Correspondent Contact MICHAEL BONO
Regulation Number892.1390
Classification Product Code
IYT  
Date Received12/30/1986
Decision Date 03/03/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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