FDA 510(k)

PRIMAGARD Isolation Gown (AAMI PB70 Level 3)

K-번호: K160361 · 2016-11-04

결정일2016-11-04

제품 코드FYC

자문 위원회SU

결정Substantially Equivalent

기기 요약

PRIMAGARD Isolation Gown (AAMI PB70 Level 3) is the device name listed in this FDA 510(k) record. The listed applicant is Primed Medical Products, Inc.. It received FDA 510(k) clearance on 2016-11-04 under 510(k) number K160361. The device is classified under product code FYC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the PRIMAGARD Isolation Gown (AAMI PB70 Level 3)?

PRIMAGARD Isolation Gown (AAMI PB70 Level 3) is a medical device that received FDA 510(k) clearance on 2016-11-04. The listed applicant is Primed Medical Products, Inc.. The 510(k) number is K160361.

When did PRIMAGARD Isolation Gown (AAMI PB70 Level 3) receive FDA 510(k) clearance?

PRIMAGARD Isolation Gown (AAMI PB70 Level 3) received FDA 510(k) clearance on 2016-11-04, under 510(k) number K160361.

Who is the listed applicant for PRIMAGARD Isolation Gown (AAMI PB70 Level 3)?

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

What is the FDA product code for PRIMAGARD Isolation Gown (AAMI PB70 Level 3)?

The FDA product code for PRIMAGARD Isolation Gown (AAMI PB70 Level 3) is FYC.

Primed Medical Products, Inc.를 신청인으로 등재한 기타 기록

K262007PRIMED AAMI Level 3 Open Back Gowns K261811PRIMED Chemotherapy Drug Tested Gowns (PM4-99450: PRIMED Chemotherapy Drug Tested Isolation Gown, Purple, AAMI Level 2; PM4-99460: PRIMED Chemotherapy Drug Tested Isolation Gown, Blue, AAMI Level 3)K252964PRIMED Surgical and Procedure Masks K242208PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)K240286PRIMED Surgical Masks and PRIMED Procedure Masks K233777PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)

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