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FDA 510(k)

CALYSTO IMAGE IV-IMAGE AND INFORMATION MANAGEMENT SYSTEM

K-Number: K040195 · 2004-04-07

ApplicantWitt Biomedical Corp
Decision Date2004-04-07
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CALYSTO IMAGE IV-IMAGE AND INFORMATION MANAGEMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Witt Biomedical Corp. It received FDA 510(k) clearance on 2004-04-07 under 510(k) number K040195. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CALYSTO IMAGE IV-IMAGE AND INFORMATION MANAGEMENT SYSTEM?

CALYSTO IMAGE IV-IMAGE AND INFORMATION MANAGEMENT SYSTEM is a medical device that received FDA 510(k) clearance on 2004-04-07. The listed applicant is Witt Biomedical Corp. The 510(k) number is K040195.

When did CALYSTO IMAGE IV-IMAGE AND INFORMATION MANAGEMENT SYSTEM receive FDA 510(k) clearance?

CALYSTO IMAGE IV-IMAGE AND INFORMATION MANAGEMENT SYSTEM received FDA 510(k) clearance on 2004-04-07, under 510(k) number K040195.

Who is the listed applicant for CALYSTO IMAGE IV-IMAGE AND INFORMATION MANAGEMENT SYSTEM?

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

What is the FDA product code for CALYSTO IMAGE IV-IMAGE AND INFORMATION MANAGEMENT SYSTEM?

The FDA product code for CALYSTO IMAGE IV-IMAGE AND INFORMATION MANAGEMENT SYSTEM is LLZ.

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Other records listing Witt Biomedical 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.

K101571XPER INFORMATION MANAGEMENT AND FLEX CARDIO PHYSIOMONITORING SYSTEMSK063840XPER INFORMATION MANAGEMENT/PHYSIOMONITORING 5 SYSTEM AND/OR VASCULAR 5, PATIENT CARE CONSOLE AND CENTRAL STATIONK063547CALYSTO SERIES IV PHYSIO-MONITORING AND INFORMATION SYSTEMK033030CALYSTO SERIES IV PATIENT CARE MONITORS AND CENTRAL STATION AND ECG MANAGEMENT SYSTEM

Related Devices (Code: LLZ)

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.

K261874Syneris PACS v.1.0.1.0SynerisK262442HipStudio AnalysisReplasia BVK261855Elucid PlaqueIQElucid Bioimaging, Inc.K254214OOOPDSTaiwan Main Orthopaedic Biotechnology Co., Ltd.K261861SPINEsim v1.0Mdsim S.A.K2620603D-RD-SRadiopharmaceutical Imaging & Dosimetry, LLC

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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