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FDA 510(k), K113708, ORTHOSCAN MOBILE DI MINI C-ARM
FDA 510(k), K113708, ORTHOSCAN MOBILE DI MINI C-ARM
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510(K) Number: K113708
Device Name: ORTHOSCAN MOBILE DI MINI C-ARM
Manufacturer: CHRIS EAVES
Device Classification Name: Image-Intensified Fluoroscopic X-Ray System, Mobile
Regulation Number: OXO
Classification Product Code: KXA
Date Received: 12/16/2011
Decision Date: 01/05/2012
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
Device Name: ORTHOSCAN MOBILE DI MINI C-ARM
Manufacturer: CHRIS EAVES
Device Classification Name: Image-Intensified Fluoroscopic X-Ray System, Mobile
Regulation Number: OXO
Classification Product Code: KXA
Date Received: 12/16/2011
Decision Date: 01/05/2012
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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