Duns Number:690593702
Device Description: WSK-1011 is a wrist type blood pressure monitor. This product is intended for noninvasive WSK-1011 is a wrist type blood pressure monitor. This product is intended for noninvasive measurement of systolic and diastolic blood pressure and pulse rate as well as calculation of pulse pressure in adults in a home healthcare environment. The product is not designed for neonatal use.Measurement is performed during the deflation of the cuff. The cuff is automatically inflated rapidly to the pressure value sufficiently above the systolic value before it shifts to the gradual deflation for measurement. The masurement ends after the diastolic blood pressure is determined and then the measurement result is displayed. Other functions such as WHO Classification indication, Pulse Pressure display, Body Motion indicator, and Irregular Pulse Rhythm indicatcion are equipped. Up to 60 readings in 2 memory banks can be stored.
Catalog Number
-
Brand Name
NISSEI
Version/Model Number
WSK-1011
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DXN
Product Code Name
System, Measurement, Blood-Pressure, Non-Invasive
Public Device Record Key
33689923-642b-4fdb-82c5-584218643582
Public Version Date
November 08, 2019
Public Version Number
3
DI Record Publish Date
September 23, 2016
Package DI Number
14931140061015
Quantity per Package
20
Contains DI Package
04931140061018
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
master carton