ALGO Pro Newborn Hearing Screener (ALGO Pro)
FDA 510(k) clearance K233649 · decided 2024-03-08
Clearance details
- K-number
- K233649
- Device name
- ALGO Pro Newborn Hearing Screener (ALGO Pro)
- Applicant
- Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)
- Decision
- Substantially Equivalent
- Date received
- 2023-11-14
- Decision date
- 2024-03-08
- Days to decision
- 115 days
- Clearance type
- Traditional
- Product code
- GWJ
- Device class
- 2
- Regulation number
- 882.1900
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Oakville, CA
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Integrity V500 (Integrity, Integrity with VEMP) (K242954) | Vivosonic, Inc. | 2024-12-19 |
| QScreen (K220139) | Path Medical GmbH | 2022-08-03 |
| ALGO 7i (K211147) | Path Medical GmbH | 2021-10-14 |
| GSI Audera Pro (K193033) | Grason Stadler | 2020-04-24 |
| SmartEP (K163326) | Intelligent Hearing Systems | 2017-09-29 |
| Eclipse with VEMP (K162037) | Interacoustics A/S | 2017-03-23 |
| ICS CHARTR EP 200 WITH VEMP (K143670) | Gn Otometrics A/S | 2015-10-23 |
| ECHO-SCREEN III PRO HEARING SCREENER WITH BARCODE SCANNER, ECHO-SCREEN III PRO HEARING SCREENER WITHOUT BARCODE SCANNER, (K141446) | Natus Medical Incorporated | 2014-08-22 |
| MADSEN ACCUSCREEN TYPE 1077 (K132957) | Gn Otometrics | 2014-02-27 |
| EARPROBE (K131141) | Path Medical GmbH | 2013-06-27 |
| HEARLAB ACA (K123701) | Frye Electronics, Inc. | 2013-04-05 |
| TYPE 1077 ACCUSCREEN (K122067) | Gn Otometrics | 2012-09-27 |
Recalls involving this device
No recalls on record reference this clearance.