iBSM
K-번호: K243837 · 2025-05-16
광고
결정일2025-05-16
제품 코드DRG
자문 위원회CV
결정Substantially Equivalent
기기 요약
iBSM is the device name listed in this FDA 510(k) record. The listed applicant is Iorbit Digital Technologies Private Limited. It received FDA 510(k) clearance on 2025-05-16 under 510(k) number K243837. The device is classified under product code DRG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
자주 묻는 질문
What is the iBSM?
iBSM is a medical device that received FDA 510(k) clearance on 2025-05-16. The listed applicant is Iorbit Digital Technologies Private Limited. The 510(k) number is K243837.
When did iBSM receive FDA 510(k) clearance?
iBSM received FDA 510(k) clearance on 2025-05-16, under 510(k) number K243837.
Who is the listed applicant for iBSM?
The FDA 510(k) record lists Iorbit Digital Technologies Private Limited as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for iBSM?
The FDA product code for iBSM is DRG.
관련 기기 (코드: DRG)
관련 기록은 이름, 제품 코드 또는 기타 메타데이터를 사용하여 자동으로 매칭됩니다. 매칭은 검증된 임상, 과학, 기업 또는 규제 상의 관계를 입증하지 않으며, 연결된 공식 출처를 검토하시기 바랍니다.
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공식 출처
FDA 데이터베이스에서 보기 →FDA Open API에서 수집된 데이터입니다. 가장 정확하고 공인된 정보는 항상 공식 레코드를 참조하시기 바랍니다.
광고