FDA 510(k)

Certa Dose Pediatric Midazolam 5mg/mL IM Syringe

K-Number: K180683 · 2018-11-07

Decision Date2018-11-07

Product CodePQX

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Certa Dose Pediatric Midazolam 5mg/mL IM Syringe is the device name listed in this FDA 510(k) record. The listed applicant is Certa Dose, Inc.. It received FDA 510(k) clearance on 2018-11-07 under 510(k) 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. The listed applicant is Certa Dose, Inc.. The 510(k) number is K180683.

When did Certa Dose Pediatric Midazolam 5mg/mL IM Syringe receive FDA 510(k) clearance?

Certa Dose Pediatric Midazolam 5mg/mL IM Syringe received FDA 510(k) clearance on 2018-11-07, under 510(k) number K180683.

Who is the listed applicant for Certa Dose Pediatric Midazolam 5mg/mL IM Syringe?

The FDA 510(k) record lists Certa Dose, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Certa Dose, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K160589Certa Dose PD Epinephrine 1mg/mL IM/SC Syringe

Related Devices (Code: PQX)

K160589Certa Dose PD Epinephrine 1mg/mL IM/SC SyringeCerta Dose, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.