Duns Number:071829634
Device Description: PHOTOTRANSDUCER; 4 PIN CONNECTOR EC6 - A plethysmograph sensor that attaches to an electro PHOTOTRANSDUCER; 4 PIN CONNECTOR EC6 - A plethysmograph sensor that attaches to an electronic plethysmograph instrument, used to measure volume changes due to blood flow changes in a limb or digit. The plethysmograph instrument measures the signal to determine changes in blood volume in the tissue under the sensor.
Catalog Number
01547
Brand Name
Hokanson
Version/Model Number
PPG sensor 4 Pin - EC6
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
K896034
Product Code
DSB
Product Code Name
Plethysmograph, Impedance
Public Device Record Key
54e8dcbc-1269-42b9-868d-8720a2cf5042
Public Version Date
October 02, 2020
Public Version Number
2
DI Record Publish Date
October 29, 2018
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 |