Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

I-SCOPE 200

K-Number: K062364 · 2006-12-06

ApplicantDongjin Medical Co., Ltd.
Decision Date2006-12-06
Product CodeDQD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

I-SCOPE 200 is the device name listed in this FDA 510(k) record. The listed applicant is Dongjin Medical Co., Ltd.. It received FDA 510(k) clearance on 2006-12-06 under 510(k) number K062364. The device is classified under product code DQD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the I-SCOPE 200?

I-SCOPE 200 is a medical device that received FDA 510(k) clearance on 2006-12-06. The listed applicant is Dongjin Medical Co., Ltd.. The 510(k) number is K062364.

When did I-SCOPE 200 receive FDA 510(k) clearance?

I-SCOPE 200 received FDA 510(k) clearance on 2006-12-06, under 510(k) number K062364.

Who is the listed applicant for I-SCOPE 200?

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

What is the FDA product code for I-SCOPE 200?

The FDA product code for I-SCOPE 200 is DQD.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Related Devices (Code: DQD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261494Smart Wireless Stethoscope (STEMO310);Smart Wireless Stethoscope (STEMO710);Smart Wireless Stethoscope (STEMO720);Smart Wireless Stethoscope (STEMO730)Shanghai Hulu Devices Co., Ltd.K261694CORE 300 Digital StethoscopeEko Health, Inc.K252915AiSteth®Ai Health Highway India Pvt., Ltd.K252089Tyto Stethoscope (G3)Tyto Care , Ltd.K252076Kneevoice Cartilage Evaluation System (750-3600-001)Kneevoice, Inc.K252284eMurmur Heart AICsd Labs

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑