FDA 510(K) K143213, INOmax DSIR Plus MRI
FDA 510(K) K143213, INOmax DSIR Plus MRI
Device Classification Name Apparatus, Nitric Oxide Delivery
510(k) Number K143213
Device Name INOmax DSIR Plus MRI
Applicant INO Therapeutics/Ikaria
Regulation Number 868.5165
Classification Product Code MRN
Subsequent Product Codes MRO MRP MRQ
Date Received 11/10/2014
Decision Date 07/10/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
Total pages: 559
Fully redacted pages: 392
Content pages: 167
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