FDA 510(k)

Puritan Opti-Tranz Cary-Blair Collection and Transport System

K-번호: K160082 · 2016-07-29

결정일2016-07-29

제품 코드JSM

자문 위원회미 (Original text: MI)

결정Substantially Equivalent

기기 요약

Puritan Opti-Tranz Cary-Blair Collection and Transport System is the device name listed in this FDA 510(k) record. The listed applicant is Puritan Medical Products, LLC. It received FDA 510(k) clearance on 2016-07-29 under 510(k) number K160082. The device is classified under product code JSM. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Puritan Opti-Tranz Cary-Blair Collection and Transport System?

Puritan Opti-Tranz Cary-Blair Collection and Transport System is a medical device that received FDA 510(k) clearance on 2016-07-29. The listed applicant is Puritan Medical Products, LLC. The 510(k) number is K160082.

When did Puritan Opti-Tranz Cary-Blair Collection and Transport System receive FDA 510(k) clearance?

Puritan Opti-Tranz Cary-Blair Collection and Transport System received FDA 510(k) clearance on 2016-07-29, under 510(k) number K160082.

Who is the listed applicant for Puritan Opti-Tranz Cary-Blair Collection and Transport System?

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

What is the FDA product code for Puritan Opti-Tranz Cary-Blair Collection and Transport System?

The FDA product code for Puritan Opti-Tranz Cary-Blair Collection and Transport System is JSM.

Puritan Medical Products, LLC를 신청인으로 등재한 기타 기록

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