Duns Number:209284132
Catalog Number
-
Brand Name
Sensor, EKG FLEX/PRO
Version/Model Number
SA9306M
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K903497
Product Code
HCC
Product Code Name
Device, Biofeedback
Public Device Record Key
a4b6adcd-5ec3-4ff8-98b8-97d1ace7f61c
Public Version Date
November 20, 2019
Public Version Number
4
DI Record Publish Date
August 31, 2017
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. | 56 |