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510(k) Data Aggregation
K Number
K113007Device Name
BIONIME DIABETES MANAGEMENT SYSTEM VI.0
Manufacturer
BIONIME CORPORATION
Date Cleared
2012-02-27
(143 days)
Product Code
JQP, NBW
Regulation Number
862.2100Why did this record match?
Product Code :
JQP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Bionime Diabetes Management System is an over-the-counter software system for use by Health Care Professionals and Patients with diabetes as an aid for managing diabetes. User(s) can transfer blood glucose readings from Rightest® Glucose meter(s) to a personal computer for the purpose of viewing, analyzing and printing the blood glucose readings, as well as to backup and to recover users' profile and data. Bionime Rightest™ GM550 and GM250 meters are compatible with Bionime Diabetes Management System.
The Bionime Diabetes Management System is not intended to provide treatment decisions, nor should it substitute professional opinion. All medical diagnoses and treatment plans should be performed by a licensed healthcare professional.
Device Description
The Bionime Diabetes Management System allows the transfer of blood glucose readings from a compatible Bionime Rightest™ Glucose Meter to a PC via USB cable.
The Data analysis features enable the user(s) to view and analyze blood glucose readings from different meal times or time periods up to 90 days. Other features including data tables, trend charts, pie charts, and printed reports are available for viewing and analyzing these readings within the different time slots.
The system includes: 1) Installation CD with setup files for Bionime GP200 Diabetes Assistant Software and Rightest™ PC Link Adapter Driver, 2) GP550 PC Link Adapter.
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K Number
K983468Device Name
FASTTAKE ADAPTER, MODEL # P/N 020-072-01
Manufacturer
SELFCARE, INC.
Date Cleared
1998-12-17
(77 days)
Product Code
JQP
Regulation Number
862.2100Why did this record match?
Product Code :
JQP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Lifescan FastTake® Adapter is an accessory to the Lifescan FastTake® Blood Glucose Meter. It provides a communication link between the FastTake® Meter and the Lifescan ONE TOUCH® Interface cable, neither of which is included. The FastTake Adapter is intended to be used for data transfer between a FastTake® Meter and a personal computer.
Device Description
The FastTake" Adapter is an accessory to the FastTake Blood Glucose Meter. lt provides a communication link between the FastTake Meter and the ONE TOUCH® cable, neither of which is included with the Adapter. The FastTake Adapter is intended to be used for data transfer between a FastTake Meter and a personal computer.
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K Number
K964460Device Name
THE ROBOLITE
Manufacturer
SHAI SYG MOTION AND INNOVATIONS, LTD.
Date Cleared
1997-01-24
(78 days)
Product Code
JQP
Regulation Number
862.2100Why did this record match?
Product Code :
JQP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ROBOLITE is an automatic needle guidance system that provides means for accurate positioning of a biopsy needle of a mammography system, to enable accurate penetration to sites of detectable breast lesions.
Device Description
The ROBOLITE is an automatic needle guidance system that provides means for accurate positioning of a biopsy needle of a mammography system, to enable accurate penetration to sites of detectable breast lesions. The ROBOLITE I S an attachment to and is mounted on a parent mammography system. It comprises a robotic biopsy unit and a film read out and motor control evaluation unit. After creating a stereotactic exposure of a previously detected breast lesion, the Robolite drives a needle holder along three orthogonal axes so that the needle penetrates the precise location of the lesion. The ROBOLITE can be used for fine for core biopsy by using the reqular needle aspiration (FNA) or carrier with a biopsy gun. needle with either plain film with a The ROBOLITE can be used X-ray or digital camera.
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