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FDA 510(k)

IMPACT

K-Number: K961694 · 1996-06-21

ApplicantMatrix Technologies Corp.
Decision Date1996-06-21
Product CodeJQW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IMPACT is the device name listed in this FDA 510(k) record. The listed applicant is Matrix Technologies Corp.. It received FDA 510(k) clearance on 1996-06-21 under 510(k) number K961694. The device is classified under product code JQW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMPACT?

IMPACT is a medical device that received FDA 510(k) clearance on 1996-06-21. The listed applicant is Matrix Technologies Corp.. The 510(k) number is K961694.

When did IMPACT receive FDA 510(k) clearance?

IMPACT received FDA 510(k) clearance on 1996-06-21, under 510(k) number K961694.

Who is the listed applicant for IMPACT?

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

What is the FDA product code for IMPACT?

The FDA product code for IMPACT is JQW.

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 PubMed Literature

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.

PMID: 42106561Impact1: Supporting Innovation in Pediatric and Maternal Health-5 Years of Outcomes.Annals of biomedical engineering ()PMID: 40498444Assessing the Impact of End-of-Life Processing on Reusable Medical Devices.Biomedical instrumentation & technology ()PMID: 39081796Recent Advances in the Design and Application of Shoulder Arthroplasty Implant Systems and Their Impact on Clinical Outcomes: A Comprehensive Review.Orthopedic research and reviews ()PMID: 37579360Impact of the Regulatory Framework on Medical Device Software Manufacturers: Are the Guidance Documents Supporting the Practical Implementation? Comment on "Clinical Decision Support and New Regulatory Frameworks for Medical Devices: Are We Ready for It? - A Viewpoint Paper".International journal of health policy and management ()

Other records listing Matrix Technologies 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.

K940390IMPACTK910140ELECTRAPETTE (R)

Related Devices (Code: JQW)

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.

K023955BD VIPER INSTRUMENTBecton, Dickinson & COK973335QUATRO SP SAMPLE PROCESSING SYSTEMS (200-499, INCLUSIVE)Zenyx Scientific , Ltd.K9801802700 SAMPLE MANAGERWaters CorporationK970420MASTERCAP AM 5.0/MASTERCAP RM 5.0Pharmacia, Inc.K970616MINI SAMPLER PROCESSORCavro Scientific Instruments, Inc.K962687GIO. DE VITA E C. S.R.L.(GDV) AUTOMATIC WASHING SYSTEMNichols Institute Diagnostics

Official Source

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