Duns Number:415868731
Device Description: EP-TRACER 70 included in the portable system setup. The EP-TRACER system is a computerized EP-TRACER 70 included in the portable system setup. The EP-TRACER system is a computerized electrophysiology measurement system designed for both regular and experimental EP studies.The EP-TRACER System is an electrophysiology measurement system used to acquire, filter, digitize, amplify, display, and record signals obtained during electrophysiological studies and related procedures. The system allows the user to monitor, display and record the signals. The system incorporates a stimulator intended to be used for diagnostic cardiac stimulation during electrophysiological testing of the heart.
Catalog Number
-
Brand Name
EP-TRACER
Version/Model Number
40SYS02
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K183266
Product Code
DQK
Product Code Name
Computer, Diagnostic, Programmable
Public Device Record Key
a9537a72-5eba-4211-9ae2-1d742db1279b
Public Version Date
September 22, 2020
Public Version Number
1
DI Record Publish Date
September 14, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |