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FDA 510(k)

CALYSTO SERIES IV PHYSIO-MONITORING AND INFORMATION SYSTEM

K-Number: K063547 · 2006-12-21

ApplicantWitt Biomedical Corp
Decision Date2006-12-21
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CALYSTO SERIES IV PHYSIO-MONITORING AND INFORMATION 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 2006-12-21 under 510(k) number K063547. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CALYSTO SERIES IV PHYSIO-MONITORING AND INFORMATION SYSTEM?

CALYSTO SERIES IV PHYSIO-MONITORING AND INFORMATION SYSTEM is a medical device that received FDA 510(k) clearance on 2006-12-21. The listed applicant is Witt Biomedical Corp. The 510(k) number is K063547.

When did CALYSTO SERIES IV PHYSIO-MONITORING AND INFORMATION SYSTEM receive FDA 510(k) clearance?

CALYSTO SERIES IV PHYSIO-MONITORING AND INFORMATION SYSTEM received FDA 510(k) clearance on 2006-12-21, under 510(k) number K063547.

Who is the listed applicant for CALYSTO SERIES IV PHYSIO-MONITORING AND INFORMATION 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 SERIES IV PHYSIO-MONITORING AND INFORMATION SYSTEM?

The FDA product code for CALYSTO SERIES IV PHYSIO-MONITORING AND INFORMATION SYSTEM is MWI.

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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 STATIONK040195CALYSTO IMAGE IV-IMAGE AND INFORMATION MANAGEMENT SYSTEMK033030CALYSTO SERIES IV PATIENT CARE MONITORS AND CENTRAL STATION AND ECG MANAGEMENT SYSTEM

Related Devices (Code: MWI)

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.

K260438Vital Signs Monitor (CLEO2)Infinium Medical, Inc.K253417Masimo Root Monitoring SystemMasimo CorporationK253196Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)Midmark CorporationK253436c-med0 alphaCosinuss GmbHK250135WAVE Clinical Platform (2.0.000)Baxter Healthcare Corp/ Excel MedicalK241766QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)Fysicon BV

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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