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FDA 510(k), K130740, NIGHTINGALE MONITORING SYSTEM
FDA 510(k), K130740, NIGHTINGALE MONITORING SYSTEM
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510(K) Number: K130740
Device Name: NIGHTINGALE MONITORING SYSTEM
Manufacturer: ZOE MEDICAL, INC.
Device Classification Name: monitor, physiological, patient (without arrhythmia detection or alarms)
Regulation Number: 870.2300
Classification Product Code: MWI
Date Received: 03/19/2013
Decision Date: 07/23/2013
Regulation Medical Specialty: Cardiovascular
Device Name: NIGHTINGALE MONITORING SYSTEM
Manufacturer: ZOE MEDICAL, INC.
Device Classification Name: monitor, physiological, patient (without arrhythmia detection or alarms)
Regulation Number: 870.2300
Classification Product Code: MWI
Date Received: 03/19/2013
Decision Date: 07/23/2013
Regulation Medical Specialty: Cardiovascular
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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