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Blood Establishment Computer Software And Accessories

Haemonetics Corporation

The following data is part of a premarket notification filed by Haemonetics Corporation with the FDA for 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.s. Food & Drug Administration   Follow Fda En Español Search Fda   Home Food Drugs Medical Devices .

Pre-market Notification Details

Device IDBK160052
510k NumberBK160052
Device Name:510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices
ClassificationBlood Establishment Computer Software And Accessories
Applicant Haemonetics Corporation 4925 Robert J Mathews Parkway suite 100 El Dorado Hills,  CA  95762
Product CodeMMH  
CFR Regulation Number864.9165 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-06-10
Decision Date2016-08-25

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00812747010088 BK160052 0

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