FDA 510(k)

셰르타 도즈 파라에핀 1mg/mL IM/SC 주사기

K-번호: K160589 · 2017-01-19

결정일2017-01-19

제품 코드PQX

자문 위원회의료장비 규제 텍스트 번역 HO [원문 텍스트가 제공되지 않았기 때문에 번역할 수 없습니다. 원문 텍스트를 제공해 주시면 번역을 도와드리겠습니다.]

결정Substantially Equivalent

기기 요약

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.

자주 묻는 질문

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.

Certa Dose, Inc.를 신청인으로 등재한 기타 기록

K180683certainty_dose_아동용_미다조람_5mg/mL_IM_시릴

공식 출처

FDA 데이터베이스에서 보기 →

FDA Open API에서 수집된 데이터입니다. 가장 정확하고 공인된 정보는 항상 공식 레코드를 참조하시기 바랍니다.