Certa Dose PD Epinephrine 1mg/mL IM/SC Syringe
K-Number: K160589 · 2017-01-19
ApplicantCerta Dose, Inc.
Decision Date2017-01-19
Product CodePQX
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Certa Dose PD Epinephrine 1mg/mL IM/SC Syringe is a medical device manufactured by Certa Dose, Inc.. It received FDA 510(k) clearance on 2017-01-19 under approval number K160589. The device is classified under product code PQX. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Certa Dose PD Epinephrine 1mg/mL IM/SC Syringe?
Certa Dose PD Epinephrine 1mg/mL IM/SC Syringe is a medical device that received FDA 510(k) clearance on 2017-01-19. It is manufactured by Certa Dose, Inc.. The 510(k) number is K160589.
When was Certa Dose PD Epinephrine 1mg/mL IM/SC Syringe approved by the FDA?
Certa Dose PD Epinephrine 1mg/mL IM/SC Syringe received FDA 510(k) clearance on 2017-01-19, under approval number K160589.
What company makes Certa Dose PD Epinephrine 1mg/mL IM/SC Syringe?
Certa Dose PD Epinephrine 1mg/mL IM/SC Syringe is manufactured by Certa Dose, Inc..
What is the FDA product code for Certa Dose PD Epinephrine 1mg/mL IM/SC Syringe?
The FDA product code for Certa Dose PD Epinephrine 1mg/mL IM/SC Syringe is PQX.
Related Clinical Trials
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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.