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FDA 510(k), K042463, HOLTER PLUS
FDA 510(k), K042463, HOLTER PLUS
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$149.00 USD
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510(K) Number: K042463
Device Name: HOLTER PLUS
Manufacturer: ROZINN ELECTRONICS, INC.
Device Classification Name: computer, diagnostic, programmable
Regulation Number: 870.1425
Classification Product Code: DQK
Date Received: 09/13/2004
Decision Date: 09/22/2004
Regulation Medical Specialty: Cardiovascular
Device Name: HOLTER PLUS
Manufacturer: ROZINN ELECTRONICS, INC.
Device Classification Name: computer, diagnostic, programmable
Regulation Number: 870.1425
Classification Product Code: DQK
Date Received: 09/13/2004
Decision Date: 09/22/2004
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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