Duns Number:399114941
Device Description: Ambulatory ECG/EEG recorder - two channel
Catalog Number
08-521
Brand Name
Actiwave
Version/Model Number
2E
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K100266
Product Code
MWJ
Product Code Name
Electrocardiograph,Ambulatory(Without Analysis)
Public Device Record Key
f4613124-5556-4dad-bea7-0ce321ee7eaa
Public Version Date
November 08, 2019
Public Version Number
4
DI Record Publish Date
September 24, 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. | 13 |