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FDA 510(k), K081140, VISENSIA
FDA 510(k), K081140, VISENSIA
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510(K) Number: K081140
Device Name: VISENSIA
Manufacturer: WAYNE NETHERCUTT
Device Classification Name: Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Regulation Number: MHX
Classification Product Code: KXA
Date Received: 04/22/2008
Decision Date: 07/17/2008
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: VISENSIA
Manufacturer: WAYNE NETHERCUTT
Device Classification Name: Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Regulation Number: MHX
Classification Product Code: KXA
Date Received: 04/22/2008
Decision Date: 07/17/2008
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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