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510(k) Data Aggregation
K Number
K974352Device Name
CARDIOVIEW 3000 SOFTWARE
Manufacturer
MICROMEDICAL, INC.
Date Cleared
1998-09-08
(293 days)
Product Code
LOS
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
MICROMEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
CARDIOVIEW™ 3000 interpretive software is a Windows-based program intended to interpret electrocardiograms. CARDIOVIEW™ 3000 interpretive software receives, displays and stores a single or standard 12-lead simultaneous ECG recording, which is transmitted either locally or transtelephonically from a Micromedical™ ECG monitor using a proprietary digital data transmission protocol. The device contains proprietary software algorithms to receive, store, analyze, and interpret the ECG signal.
Device Description
The proposed device is computer software which receives, displays and stores a single or standard 12 Lead Simultaneous ECG recording, which is transmitted either locally or transtelephonically from a Micromedical™ ECG monitor using a proprietary digital data transmission protocol. Using a complex mathematical analysis of a 12 Lead ECG, the software can also provide an interpretation of the ECG recording.
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K Number
K974220Device Name
MICROMEDICAL 12 LEAD SIMULTANEOUS CABLE
Manufacturer
MICROMEDICAL, INC.
Date Cleared
1998-08-25
(286 days)
Product Code
DPS
Regulation Number
870.2340Why did this record match?
Applicant Name (Manufacturer) :
MICROMEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Micromedical™ 12 Lead Simultaneous Cable is intended for use in acquiring a patient ECG signal via 10 leads connected to the patient's chest, converting the ECG patient DOO siguir 11-2-2, and transferring this information to a Micromedical™ monitor using a proprietary digital data transfer protocol.
Device Description
The proposed device is a 12 Lead Simultaneous Cable to connect electrodes to an electrocardiograph or to a Micromedical™ monitor.
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K Number
K974351Device Name
BIOLOG 3000 ELECTROCARDIOGRAPH
Manufacturer
MICROMEDICAL, INC.
Date Cleared
1998-04-01
(133 days)
Product Code
DPS
Regulation Number
870.2340Why did this record match?
Applicant Name (Manufacturer) :
MICROMEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Biolog™ 3000 electrocardiograph detects an ECG using a single lead patient cable or alternatively can receive ECG data detected by the Micromedical™ 12 Lead Simultaneous Cable. The Biolog™ 3000 electrocardiograph can record the ECG, display the ECG signal on a built-in LCD screen, and download the recorded ECG data to a PC running CardioView™ 3000 software or to the Micromedical™ Printer Interface. The device contains proprietary software algorithms to detect an ECG signal or receive ECG data from a patient cable, remove unwanted interference from the ECG signal, store the signal into memory, and download it to peripheral devices.
Device Description
The proposed device is an electrocardiograph that can record the ECG, display the ECG signal on a built-in LCD screen, and download the recorded ECG data to a PC running Cardio View7M 3000 software or to a Micromedical™ monitor to display the ECG signal on a personal computer. The device includes a Biolog™ 3000 unit, a User's Manual, and accessories.
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K Number
K970305Device Name
PRINTER INTERFACE
Manufacturer
MICROMEDICAL, INC.
Date Cleared
1997-08-15
(200 days)
Product Code
DXH
Regulation Number
870.2920Why did this record match?
Applicant Name (Manufacturer) :
MICROMEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Micromedical Printer Interface is used to download ECG data from a Micromedical ECG monitor and print ECG recordings on standard letter-sized paper by using one of a number of standard commercially available Canon or Hewlett Packard ink jet printers.
Device Description
The Micromedical Printer Interface receives data from a Micromedical ECG monitor and transmits it through a parallel cable to one of a number of commonly available Canon or H-P bubble jet printers to print the ECG tracing on standard-sized paper.
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K Number
K955891Device Name
CARDIOVIEW TRANSTELEPHONIC SOFTWARE
Manufacturer
MICROMEDICAL, INC.
Date Cleared
1996-10-08
(284 days)
Product Code
DPS, 74F
Regulation Number
870.2340Why did this record match?
Applicant Name (Manufacturer) :
MICROMEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
CardioView is a computerized, enhanced electronic Transtelephonic System designed for clinical indications to allow physicians or other health care providers to remotely view and analyze patient ECG data. This system is suited for small to medium health care monitoring facilities. If offers a 12 lead ECG remote monitoring system which is more comprehensive than conventional single lead transtelephonic Software.
Device Description
CardioView is a computerized, enhanced electronic Transtelephonic System designed for clinical indications to allow physicians or other health care providers to remotely view and analyze patient ECG data. This system is suited for small to medium health care monitoring facilities. If offers a 12 lead ECG remote monitoring system which is more comprehensive than conventional single lead transtelephonic Software. Both devices use a remote user input device that retains the ECG signal and transmits it over the telephone lines. Both devices can use a switched telephone network. Both devices use a modern at the Host site to communicate with the remote device and uplink the data into the Computer. Both devices use a DOS based Computer which runs in Windows "" to display data. Both devices: output a display that resembles a conventional ECG display. Both devices retain a electronically stored sample. Both act on that sample using mathematical computations. Both use a proprietary algorithm. Both use computer programming in a Windows "" environment.
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