Duns Number:115380859
Device Description: ER3C-300 System consists of the following items:ER3C-300 Audiometric Insert Earphones,ER3C ER3C-300 System consists of the following items:ER3C-300 Audiometric Insert Earphones,ER3C-84 7' cable with dual-mono 6.33 mm (1/4") plugs or ER3-19 Cable Shielded 300 Ohm 16' (ABR) or ER3-31 Shielded (ABR) Cable, or ER3-32 Shielded (ABR) Cable,ER3C-14A foam eartips (regular, 13 mm),ER3C-14B foam eartips (small, 10 mm),ER3C-14C foam eartips (large, 18 mm)
Catalog Number
-
Brand Name
N/A
Version/Model Number
ER3C-300 System
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
K930003
Product Code
EWO
Product Code Name
Audiometer
Public Device Record Key
3d31bafd-87eb-42c1-b40e-a9b8f2c657fd
Public Version Date
February 15, 2022
Public Version Number
1
DI Record Publish Date
February 07, 2022
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. | 89 |