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FDA 510(k), K101487, CHEETAH NICOM SYSTEM
FDA 510(k), K101487, CHEETAH NICOM SYSTEM
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510(K) Number: K101487
Device Name: CHEETAH NICOM SYSTEM
Manufacturer: Rhona Shanker
Device Classification Name: Computer, Diagnostic, Pre-Programmed, Single-Function
Regulation Number: DXG
Classification Product Code: KXA
Date Received: 05/28/2010
Decision Date: 07/02/2010
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: CHEETAH NICOM SYSTEM
Manufacturer: Rhona Shanker
Device Classification Name: Computer, Diagnostic, Pre-Programmed, Single-Function
Regulation Number: DXG
Classification Product Code: KXA
Date Received: 05/28/2010
Decision Date: 07/02/2010
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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