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FDA 510(k)

INFRA-LINK

K-Number: K926029 · 1993-03-26

ApplicantZygo Industries, Inc.
Decision Date1993-03-26
Product CodeIQA
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

INFRA-LINK is the device name listed in this FDA 510(k) record. The listed applicant is Zygo Industries, Inc.. It received FDA 510(k) clearance on 1993-03-26 under 510(k) number K926029. The device is classified under product code IQA. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INFRA-LINK?

INFRA-LINK is a medical device that received FDA 510(k) clearance on 1993-03-26. The listed applicant is Zygo Industries, Inc.. The 510(k) number is K926029.

When did INFRA-LINK receive FDA 510(k) clearance?

INFRA-LINK received FDA 510(k) clearance on 1993-03-26, under 510(k) number K926029.

Who is the listed applicant for INFRA-LINK?

The FDA 510(k) record lists Zygo Industries, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INFRA-LINK?

The FDA product code for INFRA-LINK is IQA.

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 Zygo Industries, Inc. 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.

K924014SECRETARYK924013MACAWK924030SCRIBEK924015PARROTK862766EPISON, ALERTING SYSTEM FOR EPILEPTICS

Related Devices (Code: IQA)

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.

K961306DELTATALKER WITH INFRAREDPrentke Romich Co.K953905IMPERIUMTeledyne Brown EngineeringK953937LIAISON COMPUTER ACCESS & ENVIRONMENTAL CONTROL SYSTEMApt Technology, Inc.K943244DEUCEApt Technology, Inc.K944585SCANNING DIRECTORPrentke Romich Co.K944345BEDSIDE BUTLERTrac Medical, 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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