Natus Medical
Echo-Screen III Pro Hearing Screening Device TEOAE, DPOAE and ABR set w/o Barcode Scanner
4manufacturers in China registered for this device type
25catalogue numbers in this listing
5510(k) clearances naming this product code
1recall
Who Else Makes It
Concentrated in Guangdong (2), Jiangsu (1), Shaanxi (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Xian Friendship Medical Electronics Co., Ltd. | Xi’An | Shaanxi | Contract manufacturer | 10 |
| Dong Guan Danchen Electrical Products Ltd. | Dong Guan | Guangdong | Contract manufacturer | 2 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
Record
| Listed by | Natus Medical Incorporated, United States |
|---|---|
| FDA product code | GWJ |
| Device type | Stimulator, Auditory, Evoked Response |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1900 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K073665 |
| Record published | 2016-10-26 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, manufacturing date, serial number |
| Distribution end date | 2026-01-07 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 000696 | Withdrawn | |
| 013506 | Withdrawn | |
| 010726 | Withdrawn | |
| 013501 | Withdrawn | |
| 000698 | Withdrawn | |
| 013515 | Withdrawn | |
| 112925144 | Withdrawn | |
| 013505 | Withdrawn | |
| 040740 | Withdrawn | |
| 013512 | Withdrawn | |
| 030697 | Withdrawn | |
| 013514 | Withdrawn | |
| 013516 | Withdrawn | |
| 013504 | Withdrawn | |
| 013503 | Withdrawn | |
| 009149 | Withdrawn | |
| 013502 | Withdrawn | |
| 010724 | Withdrawn | |
| 013511 | Withdrawn | |
| 000910 | Withdrawn | |
| 203200 | Withdrawn | |
| 010999 | Withdrawn | |
| 013513 | Withdrawn | |
| 040656 | Withdrawn | |
| 013510 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| GN Otometrics A/S | Natus Medical Denmark ApS | 117 |
| QScreen Set | Path | 24 |
| AccuScreen | Natus Medical Denmark ApS | 20 |
| Natus | Natus Medical Incorporated | 18 |
| Sentiero Advanced | Path | 14 |
| Algo Pro | Natus Medical Denmark ApS | 9 |
| Algo Pro | Xltek | 9 |
| Stimulator, Auditory, Evoked Response | Medtronic Xomed, Inc. | 7 |
| Algo 3i | Natus Medical Denmark ApS | 5 |
| Teoae probe tips | Otodynamics, Ltd. | 5 |
| Algo 5 | Natus Medical Denmark ApS | 5 |
| ICS | Natus Medical Denmark ApS | 5 |
Showing 12 of 305. All products under Stimulator, Auditory, Evoked Response
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K141446 | 2014-08-22 |
| K073665 | 2008-01-25 |
| K030823 | 2003-04-09 |
| K013137 | 2001-10-16 |
| K936039 | 1995-01-05 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2010-06-04 | Not classified | PMA | There is insufficient evidence to support any claims for safety and efficacy on the SonaMed Clarity devices. | 284 units | 2011-06-22 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.