Duns Number:341625331
Device Description: Accessory to ERT's Asthma Monitor device for professional users
Catalog Number
-
Brand Name
Asthma Monitor AMOS app
Version/Model Number
2.x
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
K183479
Product Code
BZG
Product Code Name
Spirometer, Diagnostic
Public Device Record Key
121eb1f2-ea8e-4fe3-a6cc-bb95f84c645a
Public Version Date
March 19, 2021
Public Version Number
2
DI Record Publish Date
November 04, 2019
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 32 |