ECHO-SCREEN III PRO HEARING SCREENER WITH BARCODE SCANNER, ECHO-SCREEN III PRO HEARING SCREENER WITHOUT BARCODE SCANNER,
FDA 510(k) clearance K141446 · decided 2014-08-22
Clearance details
- K-number
- K141446
- Device name
- ECHO-SCREEN III PRO HEARING SCREENER WITH BARCODE SCANNER, ECHO-SCREEN III PRO HEARING SCREENER WITHOUT BARCODE SCANNER,
- Applicant
- Natus Medical Incorporated
- Decision
- Substantially Equivalent
- Date received
- 2014-06-02
- Decision date
- 2014-08-22
- Days to decision
- 81 days
- Clearance type
- Special
- Product code
- GWJ
- Device class
- 2
- Regulation number
- 882.1900
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Seattle, WA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| OLYMPIC COOL-CAP SYSTEM (P040025/S014) | Natus Medical Incorporated | 2013-12-23 |
| OLYMPIC COOL CAP (P040025/S013) | Natus Medical Incorporated | 2013-08-29 |
| OLYMPIC COOL-CAP SYSTEM (P040025/S012) | Natus Medical Incorporated | 2012-03-27 |
| OLYMPIC COOL-CAP SYSTEM (P040025/S011) | Natus Medical Incorporated | 2010-11-23 |
| OLYMPIC COOL-CAP SYSTEM (P040025/S010) | Natus Medical Incorporated | 2010-06-28 |
| OLYMPIC COOL-CAP SYSTEM (P040025/S009) | Natus Medical Incorporated | 2009-09-18 |
| OLYMPIC COOL-CAP SYSTEM (P040025/S007) | Natus Medical Incorporated | 2009-04-22 |
| OLYMPIC COOL-CAP SYSTEM (P040025/S008) | Natus Medical Incorporated | 2008-12-24 |