Duns Number:071829634
Device Description: 110V OR 220V - A cuff inflator for rapidly inflating blood pressure cuffs to a preset pres 110V OR 220V - A cuff inflator for rapidly inflating blood pressure cuffs to a preset pressure, and for rapidly deflating blood pressure cuffs. The inflator holds the cuff pressure constant, until the clinician triggers deflation. The pressure is adjustable, and is set by the clinician according to the needs of the specialty vascular study being performed.
Catalog Number
00602
Brand Name
Hokanson
Version/Model Number
E20
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
K905367
Product Code
DXN
Product Code Name
System, Measurement, Blood-Pressure, Non-Invasive
Public Device Record Key
df8eed81-7032-413f-bd70-ccd0393220f2
Public Version Date
October 05, 2020
Public Version Number
4
DI Record Publish Date
September 16, 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 |