Certa Dose Pediatric Midazolam 5mg/mL IM Syringe
K-Number: K180683 · 2018-11-07
ApplicantCerta Dose, Inc.
Decision Date2018-11-07
Product CodePQX
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Certa Dose Pediatric Midazolam 5mg/mL IM Syringe is a medical device manufactured by Certa Dose, Inc.. It received FDA 510(k) clearance on 2018-11-07 under approval number K180683. 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 Pediatric Midazolam 5mg/mL IM Syringe?
Certa Dose Pediatric Midazolam 5mg/mL IM Syringe is a medical device that received FDA 510(k) clearance on 2018-11-07. It is manufactured by Certa Dose, Inc.. The 510(k) number is K180683.
When was Certa Dose Pediatric Midazolam 5mg/mL IM Syringe approved by the FDA?
Certa Dose Pediatric Midazolam 5mg/mL IM Syringe received FDA 510(k) clearance on 2018-11-07, under approval number K180683.
What company makes Certa Dose Pediatric Midazolam 5mg/mL IM Syringe?
Certa Dose Pediatric Midazolam 5mg/mL IM Syringe is manufactured by Certa Dose, Inc..
What is the FDA product code for Certa Dose Pediatric Midazolam 5mg/mL IM Syringe?
The FDA product code for Certa Dose Pediatric Midazolam 5mg/mL IM Syringe is PQX.
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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.