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FDA 510(k)

TC SYSTEM-COVER

K-Number: K890867 · 1989-03-14

ApplicantTransmedical Corp.
Decision Date1989-03-14
Product CodeFTA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TC SYSTEM-COVER is the device name listed in this FDA 510(k) record. The listed applicant is Transmedical Corp.. It received FDA 510(k) clearance on 1989-03-14 under 510(k) number K890867. The device is classified under product code FTA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TC SYSTEM-COVER?

TC SYSTEM-COVER is a medical device that received FDA 510(k) clearance on 1989-03-14. The listed applicant is Transmedical Corp.. The 510(k) number is K890867.

When did TC SYSTEM-COVER receive FDA 510(k) clearance?

TC SYSTEM-COVER received FDA 510(k) clearance on 1989-03-14, under 510(k) number K890867.

Who is the listed applicant for TC SYSTEM-COVER?

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

What is the FDA product code for TC SYSTEM-COVER?

The FDA product code for TC SYSTEM-COVER is FTA.

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 Transmedical 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.

K890866TC SYSTEM-HANDLE

Related Devices (Code: FTA)

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.

K112133OASYS SURGICAL LIGHT CONTROLLEROasys HealthcareK102791EASYSUITE SURGICAL LIGHT CONTROL (ESLC)Image Stream Medical, Inc.K081698MAINSTREAM OR SURGICAL LIGHT CONTROL (MSLC)Image Stream Medical, Inc.K053321LIGHT GUARD LIGHT HANDLE AND LIGHT HANDLE COVERXodus Medical, Inc.K051505SCB/STERIS OR-LIGHT INTERFACE BOXKARL STORZ Endoscopy-America, Inc.K023704KSEA SCB ACC CONTROLKARL STORZ Endoscopy-America, Inc.

Official Source

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

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