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FDA 510(k), K100040, BIOHARNESS
FDA 510(k), K100040, BIOHARNESS
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510(K) Number: K100040
Device Name: BIOHARNESS
Manufacturer: CODE CUBITT
Device Classification Name: Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Regulation Number: MHX
Classification Product Code: KXA
Date Received: 01/07/2010
Decision Date: 12/03/2010
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: BIOHARNESS
Manufacturer: CODE CUBITT
Device Classification Name: Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Regulation Number: MHX
Classification Product Code: KXA
Date Received: 01/07/2010
Decision Date: 12/03/2010
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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