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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 K013344
Device Name INTERA I/T
Applicant
Philips Medical Systems North America Co.
472 Wheelers Farms Rd.
Milford,  CT  06460
Applicant Contact PETER ALTMAN
Correspondent
Philips Medical Systems North America Co.
472 Wheelers Farms Rd.
Milford,  CT  06460
Correspondent Contact PETER ALTMAN
Regulation Number892.1000
Classification Product Code
LNH  
Date Received10/09/2001
Decision Date 12/11/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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