Duns Number:071829634
Device Description: ECG TRIGGER - A battery powered instrument used to acquire an ECG signal from a subject. T ECG TRIGGER - A battery powered instrument used to acquire an ECG signal from a subject. The instrument filters and amplifies the patient's ECG R-wave, then sends the signal to a parent device via and optically isolated interface cable. The output signal can be used by the parent device to synchronize another event with the subject’s R-Wave. The waveform is NOT used for analysis or diagnosis due to the ECG signal filtering.
Catalog Number
00334
Brand Name
Hokanson
Version/Model Number
RT2000
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K023707
Product Code
JOM
Product Code Name
Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
Public Device Record Key
b5f0b38a-0bb6-4ec1-a521-6cc0ece3e97f
Public Version Date
October 05, 2020
Public Version Number
4
DI Record Publish Date
September 22, 2016
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. | 218 |