FDA PMA

테스트, 성인 및 소아(숨쉬기) 요오르스탄산암모니아

PMA 번호: P170022 · 2026-02-05

신청자Arj Medical, Inc.

결정일2026-02-05

PMA 번호P170022

제품 코드OZA

의료기기 등급등급 3

의학적 전문분야M

규정 번호21 CFR 8

자문 위원회미 (Original text: MI)

기기 요약

Test, urea adult and pediatric (breath), is the device name listed in this FDA 510(k) record. The listed applicant is Arj Medical, Inc.. It received FDA 510(k) clearance on 2026-02-05. The device is classified under product code OZA. It was reviewed by the MI advisory panel.

자주 묻는 질문

What is the Test, urea adult and pediatric (breath),?

Test, urea adult and pediatric (breath), is a medical device that received FDA 510(k) clearance on 2026-02-05. The listed applicant is Arj Medical, Inc..

When did Test, urea adult and pediatric (breath), receive FDA 510(k) clearance?

The clearance date for Test, urea adult and pediatric (breath), can be found in the official FDA records.

Who is the listed applicant for Test, urea adult and pediatric (breath),?

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

What is the FDA product code for Test, urea adult and pediatric (breath),?

The FDA product code for Test, urea adult and pediatric (breath), is OZA.

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