Duns Number:071829634
Device Description: DOPPLER AND PLETHYSMOGRAPH SYSTEM - The line-powered instrument contains a direction-sensi DOPPLER AND PLETHYSMOGRAPH SYSTEM - The line-powered instrument contains a direction-sensing continuous wave Doppler, a photo plethysmograph, and a pneumo plethysmograph. Several types of diagnostic tests can be performed allowing the user to choose the most appropriate one for the particular study of interest. A built-in two speed chart recorder can record the waveform from the selected instrument mode. A digital output is included so waveforms can also be captured in computer software.
Catalog Number
00498
Brand Name
Hokanson
Version/Model Number
MD35
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
e1265681-bb9b-4679-9bad-0976801b2381
Public Version Date
October 01, 2020
Public Version Number
1
DI Record Publish Date
September 23, 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. | 218 |