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FDA 510(k), K990170, HOLTER 2000
FDA 510(k), K990170, HOLTER 2000
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510(K) Number: K990170
Device Name: HOLTER 2000
Manufacturer: ZYMED MEDICAL INSTRUMENTATION
Device Classification Name: electrocardiograph, ambulatory, with analysis algorithm
Regulation Number: 870.2800
Classification Product Code: MLO
Date Received: 01/19/1999
Decision Date: 04/13/1999
Regulation Medical Specialty: Cardiovascular
Device Name: HOLTER 2000
Manufacturer: ZYMED MEDICAL INSTRUMENTATION
Device Classification Name: electrocardiograph, ambulatory, with analysis algorithm
Regulation Number: 870.2800
Classification Product Code: MLO
Date Received: 01/19/1999
Decision Date: 04/13/1999
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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