Duns Number:962519208
Device Description: The ALGO® 3i Newborn Hearing Screener is a portable, noninvasive device for screening the The ALGO® 3i Newborn Hearing Screener is a portable, noninvasive device for screening the hearing of infants between the ages of 34 weeks corrected gestational age and six months. The screener uses Natus’ AABR® technology. Babies should be well enough for hospital discharge, and should be asleep or in a quiet state at the time of screening. The ALGO 3i screener is simple to operate and does not require special technical skills or interpretation of results. Basic training with the equipment is sufficient to learn how to screen infants correctly. A typical screening can be completed in 15 minutes or less in any clinical environment (i.e. well-baby nursery, NICU, mother’s bedside, audiology suite, outpatient clinic, or doctor’s office).
Catalog Number
040695, 040969
Brand Name
ALGO 3i Newborn Hearing Screener
Version/Model Number
Algo 3i
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)
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Device labeled as "Not made with natural rubber latex"
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For Single-Use
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Prescription Use (Rx)
-
Over the Counter (OTC)
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Kit
-
Combination Product
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Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K030823
Product Code
GWJ
Product Code Name
Stimulator, Auditory, Evoked Response
Public Device Record Key
be3253a5-b82b-4932-91b4-b514f0d54fe0
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 28, 2017
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 | 24 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 302 |
| 3 | A medical device with high risk that requires premarket approval | 5 |