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510(k) Data Aggregation
K Number
K010058Device Name
IMAGE IV DICOM IMAGE ARCHIVAL PACS NETWORK
Manufacturer
WITT BIOMEDICAL CORPORATION
Date Cleared
2001-03-21
(72 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
WITT BIOMEDICAL CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K973474Device Name
WITT BIOMEDICAL CENTRAL STATION MONITORING SYSTEM AND WITT BIOMEDICAL ADVANCED PATIENT CARE MONITORING UNITS
Manufacturer
WITT BIOMEDICAL CORPORATION
Date Cleared
1998-03-13
(182 days)
Product Code
MHX
Regulation Number
870.1025Why did this record match?
Applicant Name (Manufacturer) :
WITT BIOMEDICAL CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Witt Biomedical Central Station Monitor and Advanced Patient Care Monitoring Units are designed to provide continuous monitoring of patient physiological parameters, generate alarms (both visual and audible), alerting operator to anomalous occurrences and facilitate timely responses. The Witt Biomedical Central Station Monitor and/or Advanced Patient Care Monitoring unit are intended for use in hospital environments including surgical intensive care, respiratory intensive care, coronary care, post anesthesia recovery, operating room, medical intensive care, pediatrics intensive care and patient holding areas of health care facilities. The Witt Biomedical Central Station Monitor and Advanced Patient Care Monitoring Unit offers a thorough display of monitoring parameters which use proven algorithms and are displayed in a logical, easily understood format that requires only familiarity to the users of any Witt Biomedical system.
The Witt Biomedical Central Station Monitor and Advanced Patient Care Monitoring Units are intended to be used by trained hospital personnel with training on the operation of this equipment.
Device Description
Witt Biomedical Corporation Central Station with Advanced Patient Care Monitoring System.
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