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FDA 510(k)

COMFORTRAC, CT90 & CT100 BI-PHASICS

K-Number: K892669 · 1989-05-26

ApplicantComfortrac Systems
Decision Date1989-05-26
Product CodeISA
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

COMFORTRAC, CT90 & CT100 BI-PHASICS is the device name listed in this FDA 510(k) record. The listed applicant is Comfortrac Systems. It received FDA 510(k) clearance on 1989-05-26 under 510(k) number K892669. The device is classified under product code ISA. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMFORTRAC, CT90 & CT100 BI-PHASICS?

COMFORTRAC, CT90 & CT100 BI-PHASICS is a medical device that received FDA 510(k) clearance on 1989-05-26. The listed applicant is Comfortrac Systems. The 510(k) number is K892669.

When did COMFORTRAC, CT90 & CT100 BI-PHASICS receive FDA 510(k) clearance?

COMFORTRAC, CT90 & CT100 BI-PHASICS received FDA 510(k) clearance on 1989-05-26, under 510(k) number K892669.

Who is the listed applicant for COMFORTRAC, CT90 & CT100 BI-PHASICS?

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

What is the FDA product code for COMFORTRAC, CT90 & CT100 BI-PHASICS?

The FDA product code for COMFORTRAC, CT90 & CT100 BI-PHASICS is ISA.

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 Comfortrac Systems 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.

K901971COMFORTRAC TABLE MODEL CT-1000

Related Devices (Code: ISA)

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.

K243488VMAT PROTermosaludK240358ShockPhysio Mobile (model SW3200 Basic)Shenzhen Dongdixin Technology Co., Ltd.K221865BTL-094BTL Industries, Inc.K210166Omnispec ED1000Medispec, Ltd.K213120OW100S (model OW100S-US)Tissue Regeneration Technologies, LLC Dba AS Softwave TrtK220538DolorClast RadialE.M.S Electro Medical Systems S.A

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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