BD SafeAssist
K-Number: K161553 · 2016-07-06
ApplicantBecton, Dickinson and Company
Decision Date2016-07-06
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
BD SafeAssist is a medical device manufactured by Becton, Dickinson and Company. It received FDA 510(k) clearance on 2016-07-06 under approval number K161553. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the BD SafeAssist?
BD SafeAssist is a medical device that received FDA 510(k) clearance on 2016-07-06. It is manufactured by Becton, Dickinson and Company. The 510(k) number is K161553.
When was BD SafeAssist approved by the FDA?
BD SafeAssist received FDA 510(k) clearance on 2016-07-06, under approval number K161553.
What company makes BD SafeAssist?
BD SafeAssist is manufactured by Becton, Dickinson and Company.
What is the FDA product code for BD SafeAssist?
The FDA product code for BD SafeAssist is FMI.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.