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

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 IDBK150360
510k NumberBK150360
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 Received2015-12-22
Decision Date2016-03-11

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00812747010118 BK150360 0
00812747010101 BK150360 0

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.