Duns Number:551540334
Device Description: ALGO 7i Base Kit containing:1x 101049 ALGO 7i1x 101121 ALGO7i Multidata Cable1x 100524 Pow ALGO 7i Base Kit containing:1x 101049 ALGO 7i1x 101121 ALGO7i Multidata Cable1x 100524 Power Supply1x 100525-EU Power Supply Adapter EU1x 100525-US Power Supply Adapter US1x 100525-UK Power Supply Adapter UK1x 100525-AUS Power Supply Adapter AUS1x 101092-E ALGO 7i Basinet Hook1x 101100-E ALGO 7i Check Kit1x 101124-EN ALGO 7i User Manual1x 101118 USB Stick1x 100418 USB Cable1x 101201 ALGO 7i Backback Set
Catalog Number
A7i-101127
Brand Name
ALGO 7i Set 1
Version/Model Number
101127
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
K211147
Product Code
GWJ
Product Code Name
Stimulator, Auditory, Evoked Response
Public Device Record Key
2a0ec8e3-5c05-4049-a677-420222592fa0
Public Version Date
November 08, 2021
Public Version Number
1
DI Record Publish Date
October 29, 2021
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 | 18 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 152 |