FDA 510(k)

RT Carbon ECG Leads

K-번호: K240087 · 2024-09-13

결정일2024-09-13

제품 코드DSA

자문 위원회CV

결정Substantially Equivalent

기기 요약

RT Carbon ECG Leads is the device name listed in this FDA 510(k) record. The listed applicant is Ivy Biomedical Systems, Inc.. It received FDA 510(k) clearance on 2024-09-13 under 510(k) number K240087. The device is classified under product code DSA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the RT Carbon ECG Leads?

RT Carbon ECG Leads is a medical device that received FDA 510(k) clearance on 2024-09-13. The listed applicant is Ivy Biomedical Systems, Inc.. The 510(k) number is K240087.

When did RT Carbon ECG Leads receive FDA 510(k) clearance?

RT Carbon ECG Leads received FDA 510(k) clearance on 2024-09-13, under 510(k) number K240087.

Who is the listed applicant for RT Carbon ECG Leads?

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

What is the FDA product code for RT Carbon ECG Leads?

The FDA product code for RT Carbon ECG Leads is DSA.

Ivy Biomedical Systems, Inc.를 신청인으로 등재한 기타 기록

K202138Cardiac Trigger Monitor K203653MRI PPG Patient Cable K192852MRI ECG Patient Cable K171778MR Wireless Gating System, Model WGS-100 K170828Cardiac Trigger Monitor K151781Cardiac Trigger Monitor, Cardiac & Regulatory Synchronization Monitor

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관련 기기 (코드: DSA)

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