FDA 510(k)

Certa Dose PD 肾上腺素 1mg/mL IM/SC 注射器

K号: K160589 · 2017-01-19

决定日期2017-01-19

产品代码PQX

咨询委员会医疗设备监管文本翻译如下： HO 请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。

决定实质等同

器械摘要

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.

常见问题

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.

列明Certa Dose, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K180683Certa Dose 儿童咪达唑仑 5mg/mL IM 注射器

官方来源

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