FDA 510(k)

SepaSperm Washing Solution, SepaSperm Solution

K-번호: K190199 · 2019-09-26

결정일2019-09-26

제품 코드MQL

자문 위원회OB

결정Substantially Equivalent

기기 요약

SepaSperm Washing Solution, SepaSperm Solution is the device name listed in this FDA 510(k) record. The listed applicant is Kitazato Corporation. It received FDA 510(k) clearance on 2019-09-26 under 510(k) number K190199. The device is classified under product code MQL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the SepaSperm Washing Solution, SepaSperm Solution?

SepaSperm Washing Solution, SepaSperm Solution is a medical device that received FDA 510(k) clearance on 2019-09-26. The listed applicant is Kitazato Corporation. The 510(k) number is K190199.

When did SepaSperm Washing Solution, SepaSperm Solution receive FDA 510(k) clearance?

SepaSperm Washing Solution, SepaSperm Solution received FDA 510(k) clearance on 2019-09-26, under 510(k) number K190199.

Who is the listed applicant for SepaSperm Washing Solution, SepaSperm Solution?

The FDA 510(k) record lists Kitazato Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SepaSperm Washing Solution, SepaSperm Solution?

The FDA product code for SepaSperm Washing Solution, SepaSperm Solution is MQL.

Kitazato Corporation를 신청인으로 등재한 기타 기록

K260248Ultra-Fast Warm K251305Ultra-Fast Vitri; Ultra-Fast Warm K200249Sequential Culture Media (Fertilization Medium [without HSA/rHA, with HSA, with rHA], Cleavage Medium [without HSA/rHA, with HSA, with rHA], Blastocyst Medium [without HSA/rHA, with HSA, with rHA])K193522iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHA K192845Sperm Freeze, Sperm Fridge K192540Kitazato ET Catheters

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