The following data is part of a premarket notification filed by Natus Medical Incorporated with the FDA for Echo-screen Iii Pro Hearing Screener With Barcode Scanner, Echo-screen Iii Pro Hearing Screener Without Barcode Scanner,.
| Device ID | K141446 |
| 510k Number | K141446 |
| Device Name: | ECHO-SCREEN III PRO HEARING SCREENER WITH BARCODE SCANNER, ECHO-SCREEN III PRO HEARING SCREENER WITHOUT BARCODE SCANNER, |
| Classification | Stimulator, Auditory, Evoked Response |
| Applicant | NATUS MEDICAL INCORPORATED 5900 FIRST AVENUE SOUTH Seattle, WA 98108 |
| Contact | Judy Buckham |
| Correspondent | Judy Buckham NATUS MEDICAL INCORPORATED 5900 FIRST AVENUE SOUTH Seattle, WA 98108 |
| Product Code | GWJ |
| CFR Regulation Number | 882.1900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-02 |
| Decision Date | 2014-08-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382830054942 | K141446 | 000 |
| 00382830044578 | K141446 | 000 |
| 00382830044561 | K141446 | 000 |
| 00382830044554 | K141446 | 000 |
| 00382830044547 | K141446 | 000 |
| 00382830044530 | K141446 | 000 |
| 00382830045353 | K141446 | 000 |
| 00382830045339 | K141446 | 000 |
| 00382830045315 | K141446 | 000 |
| 00382830045292 | K141446 | 000 |
| 00382830045278 | K141446 | 000 |
| 00382830044585 | K141446 | 000 |
| 00382830044592 | K141446 | 000 |
| 00382830044738 | K141446 | 000 |
| 00382830044721 | K141446 | 000 |
| 00382830044714 | K141446 | 000 |
| 00382830044660 | K141446 | 000 |
| 00382830044653 | K141446 | 000 |
| 00382830044646 | K141446 | 000 |
| 00382830044639 | K141446 | 000 |
| 00382830044622 | K141446 | 000 |
| 00382830044615 | K141446 | 000 |
| 00382830044608 | K141446 | 000 |
| 00382830045247 | K141446 | 000 |