FDA 510(k)

WITT BIOMEDICAL CENTRAL STATION MONITORING SYSTEM AND WITT BIOMEDICAL ADVANCED PATIENT CARE MONITORING UNITS

K-Number: K973474 · 1998-03-13

Decision Date1998-03-13

Product CodeMHX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

WITT BIOMEDICAL CENTRAL STATION MONITORING SYSTEM AND WITT BIOMEDICAL ADVANCED PATIENT CARE MONITORING UNITS is the device name listed in this FDA 510(k) record. The listed applicant is Witt Biomedical Corporation. It received FDA 510(k) clearance on 1998-03-13 under 510(k) number K973474. The device is classified under product code MHX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WITT BIOMEDICAL CENTRAL STATION MONITORING SYSTEM AND WITT BIOMEDICAL ADVANCED PATIENT CARE MONITORING UNITS?

WITT BIOMEDICAL CENTRAL STATION MONITORING SYSTEM AND WITT BIOMEDICAL ADVANCED PATIENT CARE MONITORING UNITS is a medical device that received FDA 510(k) clearance on 1998-03-13. The listed applicant is Witt Biomedical Corporation. The 510(k) number is K973474.

When did WITT BIOMEDICAL CENTRAL STATION MONITORING SYSTEM AND WITT BIOMEDICAL ADVANCED PATIENT CARE MONITORING UNITS receive FDA 510(k) clearance?

WITT BIOMEDICAL CENTRAL STATION MONITORING SYSTEM AND WITT BIOMEDICAL ADVANCED PATIENT CARE MONITORING UNITS received FDA 510(k) clearance on 1998-03-13, under 510(k) number K973474.

Who is the listed applicant for WITT BIOMEDICAL CENTRAL STATION MONITORING SYSTEM AND WITT BIOMEDICAL ADVANCED PATIENT CARE MONITORING UNITS?

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

What is the FDA product code for WITT BIOMEDICAL CENTRAL STATION MONITORING SYSTEM AND WITT BIOMEDICAL ADVANCED PATIENT CARE MONITORING UNITS?

The FDA product code for WITT BIOMEDICAL CENTRAL STATION MONITORING SYSTEM AND WITT BIOMEDICAL ADVANCED PATIENT CARE MONITORING UNITS is MHX.

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Other records listing Witt Biomedical Corporation as applicant

K010058IMAGE IV DICOM IMAGE ARCHIVAL PACS NETWORK K950436WITT BIOMEDICAL SERIES IV K945582WITT BIOMEDICAL IMAGE III K923054WITT BIOMEDICAL SERIES II-EP K880258WITT BIOMEDICAL VX-80

Related Devices (Code: MHX)

K260656Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP MM; TruSignal SpO2 MM 1.8M; TruSignal SpO2 MM 3.0MGE Healthcare Finland Oy K260343Carescape Canvas 1000; Carescape Canvas Smart DisplayGE Healthcare Finland Oy K260579Infinity® Acute Care System (IACS) – VG8.1Draeger Medical Systems, Inc.K251508Telemetry Monitor (iT30, iT50)Edan Instruments, Inc.K253277Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.K254209Radius VSM and AccessoriesMasimo Corporation

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.