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FDA 510(k), K052013, ACHIEVA 1.5T & INERA 1.5T FAMILY
FDA 510(k), K052013, ACHIEVA 1.5T & INERA 1.5T FAMILY
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510(K) Number: K052013
Device Name: ACHIEVA 1.5T & INERA 1.5T FAMILY
Manufacturer: LYNN T HARMER
Device Classification Name: System, Nuclear Magnetic Resonance Imaging
Regulation Number: LNH
Classification Product Code: KXA
Date Received: 07/26/2005
Decision Date: 08/02/2005
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
Device Name: ACHIEVA 1.5T & INERA 1.5T FAMILY
Manufacturer: LYNN T HARMER
Device Classification Name: System, Nuclear Magnetic Resonance Imaging
Regulation Number: LNH
Classification Product Code: KXA
Date Received: 07/26/2005
Decision Date: 08/02/2005
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
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