LogoFDA 510(k) Search
K Number
K982617
Device Name
TRACER
Manufacturer
HEARTLAND MEDICAL SYSTEMS, INC.
Date Cleared
1999-04-09

(256 days)

Product Code
MWJ,MJW
Regulation Number
870.2800
Type
Traditional
Panel
CV
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

For patient’s who may be experiencing cardiac events symptomatic pulse rate abnormalities.

Device Description

TRACER

AI/ML Overview

The provided text is a 510(k) premarket notification approval letter from the FDA for a device named "TRACER." It does not contain information about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment. Therefore, I cannot generate the requested table and study description based on the provided text.

The document primarily focuses on:

  • The FDA's decision that the TRACER device is substantially equivalent to legally marketed predicate devices.
  • Regulatory classification (Class II, product code MJW).
  • General controls and potential additional controls (Special Controls or Premarket Approval) applicable to the device.
  • Contact information for various FDA offices.
  • A brief mention of "Indications For Use" on the enclosure, which is not fully visible, but hints at cardiac events and symptomatic pulse rate abnormalities.

To provide the requested information, a document specifically detailing the pre-market studies and their results would be needed.

§ 870.2800 Medical magnetic tape recorder.

(a)
Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.(b)
Classification. Class II (performance standards).