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510(k) Data Aggregation
K Number
K982034Device Name
E-FAX SYSTEM
Manufacturer
Date Cleared
1999-02-19
(254 days)
Product Code
Regulation Number
870.2920Why did this record match?
Applicant Name (Manufacturer) :
BLAKBAG, LTD., DIVISION OF COHERENT SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The E-FAX Pacemaker Services software is designed to provide an additional program directory in the E-FAX System to support scheduling, receiving, and annotating transtelephonic pacemaker magnet testing and ECG strips using a pacemaker telephonic transmitter provided to the patient by his/her physician.
Device Description
The E-FAX Pacemaker Services software is an add on to the present E-FAX System software (K932859), that provides additional program directory in the E-FAX System to support scheduling, receiving, and annotating transtelephonic pacemaker magnet testing using a pacemaker transmitter provided to the patient by his/her physician.
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