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FDA 510(k), K112877, COMEN MULTI-PARAMETER PATIENT MONITOR
FDA 510(k), K112877, COMEN MULTI-PARAMETER PATIENT MONITOR
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510(K) Number: K112877
Device Name: COMEN MULTI-PARAMETER PATIENT MONITOR
Manufacturer: GOLDWAY (US), INC.
Device Classification Name: monitor, physiological, patient (without arrhythmia detection or alarms)
Regulation Number: 870.2300
Classification Product Code: MWI
Date Received: 09/30/2011
Decision Date: 11/07/2012
Regulation Medical Specialty: Cardiovascular
Device Name: COMEN MULTI-PARAMETER PATIENT MONITOR
Manufacturer: GOLDWAY (US), INC.
Device Classification Name: monitor, physiological, patient (without arrhythmia detection or alarms)
Regulation Number: 870.2300
Classification Product Code: MWI
Date Received: 09/30/2011
Decision Date: 11/07/2012
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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