• FDA DYMISTA NDA 202236 approval records — 22 FDA documents, 848 pages
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FDA 510(k) K060065, CAPNOSTREAM20 TWO PARAMETER BEDSIDE MONITOR & CAPNOSTREAM10 ONE PARAMETER BEDSIDE MONITOR, by Oridion Capnography, Inc.

FDA 510(k) K060065, CAPNOSTREAM20 TWO PARAMETER BEDSIDE MONITOR & CAPNOSTREAM10 ONE PARAMETER BEDSIDE MONITOR, by Oridion Capnography, Inc.

$646.75 USD
$646.75 USD
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510(K) Number: K060065
Device Name: CAPNOSTREAM20 TWO PARAMETER BEDSIDE MONITOR & CAPNOSTREAM10 ONE PARAMETER BEDSIDE MONITOR
Manufacturer: Oridion Capnography, Inc.
Device Classification Name: oximeter
Regulation Number: 870.2700
Classification Product Code: DQA
Date Received: 01/09/2006
Decision Date: 05/04/2006
Regulation Medical Specialty: Cardiovascular

Total pages: 941
Fully redacted pages: 664
Content pages: 277
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