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FDA 510(k)

MAGBODY DT-1200, DT-1200T, DT-1200M, DT-1200PT, DT-1200PM

K-Number: K053285 · 2006-01-05

ApplicantDurtech System Corp.
Decision Date2006-01-05
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

MAGBODY DT-1200, DT-1200T, DT-1200M, DT-1200PT, DT-1200PM is the device name listed in this FDA 510(k) record. The listed applicant is Durtech System Corp.. It received FDA 510(k) clearance on 2006-01-05 under 510(k) number K053285. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAGBODY DT-1200, DT-1200T, DT-1200M, DT-1200PT, DT-1200PM?

MAGBODY DT-1200, DT-1200T, DT-1200M, DT-1200PT, DT-1200PM is a medical device that received FDA 510(k) clearance on 2006-01-05. The listed applicant is Durtech System Corp.. The 510(k) number is K053285.

When did MAGBODY DT-1200, DT-1200T, DT-1200M, DT-1200PT, DT-1200PM receive FDA 510(k) clearance?

MAGBODY DT-1200, DT-1200T, DT-1200M, DT-1200PT, DT-1200PM received FDA 510(k) clearance on 2006-01-05, under 510(k) number K053285.

Who is the listed applicant for MAGBODY DT-1200, DT-1200T, DT-1200M, DT-1200PT, DT-1200PM?

The FDA 510(k) record lists Durtech System Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MAGBODY DT-1200, DT-1200T, DT-1200M, DT-1200PT, DT-1200PM?

The FDA product code for MAGBODY DT-1200, DT-1200T, DT-1200M, DT-1200PT, DT-1200PM is IPF.

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

Other records listing Durtech System Corp. as applicant

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.

K053284MAGBODY DT-600

Related Devices (Code: IPF)

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.

K253542Apollo Quattro (APQ-10M)Weero Co., Ltd.K252816High Tone Power therapy (HiToP) (Model: HiToP PNP)Mohammadali NezakatiK260142StimelMD (SSMD) systemMotion Informatics ltd.K251083Compact IIEnraf-Nonius, B.V.K241433EVE Synergy (EVE-20M)Weero Co., Ltd.K241488TrainFES AdvanceTrainfes

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.

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