ON-Q* Pump with Bolus
K-Number: K181360 · 2019-03-22
ApplicantHalyard Health
Decision Date2019-03-22
Product CodeMEB
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
ON-Q* Pump with Bolus is a medical device manufactured by Halyard Health. It received FDA 510(k) clearance on 2019-03-22 under approval number K181360. The device is classified under product code MEB. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ON-Q* Pump with Bolus?
ON-Q* Pump with Bolus is a medical device that received FDA 510(k) clearance on 2019-03-22. It is manufactured by Halyard Health. The 510(k) number is K181360.
When was ON-Q* Pump with Bolus approved by the FDA?
ON-Q* Pump with Bolus received FDA 510(k) clearance on 2019-03-22, under approval number K181360.
What company makes ON-Q* Pump with Bolus?
ON-Q* Pump with Bolus is manufactured by Halyard Health.
What is the FDA product code for ON-Q* Pump with Bolus?
The FDA product code for ON-Q* Pump with Bolus is MEB.
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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.