FDA 510(k)

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

K-Number: K160589 · 2017-01-19

Decision Date2017-01-19

Product CodePQX

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Certa Dose PD Epinephrine 1mg/mL IM/SC 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 2017-01-19 under 510(k) 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. The listed applicant is Certa Dose, Inc.. The 510(k) number is K160589.

When did Certa Dose PD Epinephrine 1mg/mL IM/SC Syringe receive FDA 510(k) clearance?

Certa Dose PD Epinephrine 1mg/mL IM/SC Syringe received FDA 510(k) clearance on 2017-01-19, under 510(k) number K160589.

Who is the listed applicant for Certa Dose PD Epinephrine 1mg/mL IM/SC 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 PD Epinephrine 1mg/mL IM/SC Syringe?

The FDA product code for Certa Dose PD Epinephrine 1mg/mL IM/SC 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.

K180683Certa Dose Pediatric Midazolam 5mg/mL IM Syringe

Related Devices (Code: PQX)

K180683Certa Dose Pediatric Midazolam 5mg/mL IM 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.