Duns Number:198227881
Device Description: Welch Allyn OAE Hearing Screener with Charging Stand, Thermal Printer, Bluetooth Wireless Welch Allyn OAE Hearing Screener with Charging Stand, Thermal Printer, Bluetooth Wireless and USB Connectivity, Single Use Ear Tip Starter Kit—3mm to 15 mm sizes (#39420), Calibration Certificate, and Data Manager Software; 100- 240 V, 50- 60 Hz AC, Lithium-Ion Integrated Battery, IEC Plug Type-B, -C, -G, and -I
Catalog Number
39500
Brand Name
Welch Allyn, Inc.
Version/Model Number
901031
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
K180287
Product Code
EWO
Product Code Name
AUDIOMETER
Public Device Record Key
08048028-2e7a-4253-b8c3-9d8e5c39cf22
Public Version Date
September 05, 2019
Public Version Number
1
DI Record Publish Date
August 28, 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 | 374 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4080 |
| 3 | A medical device with high risk that requires premarket approval | 1 |