The following data is part of a premarket notification filed by Gn Otometrics with the FDA for Madsen Accuscreen Type 1077.
| Device ID | K132957 |
| 510k Number | K132957 |
| Device Name: | MADSEN ACCUSCREEN TYPE 1077 |
| Classification | Stimulator, Auditory, Evoked Response |
| Applicant | GN OTOMETRICS 8870 RAVELLO CT Naples, FL 34114 |
| Contact | Daniel Kamm, P.e. |
| Correspondent | Daniel Kamm, P.e. GN OTOMETRICS 8870 RAVELLO CT Naples, FL 34114 |
| Product Code | GWJ |
| CFR Regulation Number | 882.1900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-20 |
| Decision Date | 2014-02-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05713315000546 | K132957 | 000 |
| 05713315000379 | K132957 | 000 |
| 05713315000362 | K132957 | 000 |
| 05713315008672 | K132957 | 000 |
| 05713315008641 | K132957 | 000 |
| 05713315008849 | K132957 | 000 |
| 05713315008832 | K132957 | 000 |
| 05713315008825 | K132957 | 000 |
| 05713315008818 | K132957 | 000 |
| 05713315009006 | K132957 | 000 |
| 05713315008993 | K132957 | 000 |
| 05713315008986 | K132957 | 000 |
| 05713315008979 | K132957 | 000 |
| 05713315008962 | K132957 | 000 |
| 05713315000386 | K132957 | 000 |
| 05713315000393 | K132957 | 000 |
| 05713315000539 | K132957 | 000 |
| 05713315000522 | K132957 | 000 |
| 05713315000508 | K132957 | 000 |
| 05713315000492 | K132957 | 000 |
| 05713315000485 | K132957 | 000 |
| 05713315000478 | K132957 | 000 |
| 05713315000461 | K132957 | 000 |
| 05713315000454 | K132957 | 000 |
| 05713315000447 | K132957 | 000 |
| 05713315000430 | K132957 | 000 |
| 05713315000423 | K132957 | 000 |
| 05713315000416 | K132957 | 000 |
| 05713315000409 | K132957 | 000 |
| 05713315008955 | K132957 | 000 |