Duns Number:177242153
Device Description: The EXPMT 2000 will test and verify all the functions of any External Pacemaker including, The EXPMT 2000 will test and verify all the functions of any External Pacemaker including, transcutaneous and Atrial and Ventricular sequential pacemakers.Operation of the analyzer is menu driven via eight tactile keys and a large four line LCD display. Test measurements are simultaneously presented on the display. Five ECG snaps are standard along with an RS-232 serial port that allows for printing both a heading and test measurements on a separate printer. Information may also be sent to an external device. The external test load has twelve user-selectable loads from 100 to 1000 Ohms for use with transcutaneous pacemakers.
Catalog Number
950
Brand Name
External Pacemaker Ananlyzer
Version/Model Number
EXPMT 2000
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K961582
Product Code
DTC
Product Code Name
Analyzer, Pacemaker Generator Function
Public Device Record Key
7132e39e-e704-4618-bee4-99f5f522293b
Public Version Date
July 20, 2018
Public Version Number
4
DI Record Publish Date
June 16, 2017
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. | 3 |