Duns Number:198227881
Device Description: Welch Allyn AudioScope 3 Screening Audiometer with Charging Stand, Recording Forms (Qty. 2 Welch Allyn AudioScope 3 Screening Audiometer with Charging Stand, Recording Forms (Qty. 25), AudioSpec Ear Speculum Set (#23400); 230-250 V, 50-60 Hz AC, Nickel-Cadmium (#72300) Battery; IEC Plug Type-I
Catalog Number
92686
Brand Name
Welch Allyn, Inc.
Version/Model Number
901035
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
-
Product Code
EWO
Product Code Name
AUDIOMETER
Public Device Record Key
94a70dfa-f730-4aaa-999c-024c8b93fe87
Public Version Date
June 15, 2018
Public Version Number
3
DI Record Publish Date
September 21, 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 |
|---|---|---|
| 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 |