GSI AUDERA
Audiometer
NICOLET BIOMEDICAL
The following data is part of a premarket notification filed by Nicolet Biomedical with the FDA for Gsi Audera.
Pre-market Notification Details
| Device ID | K011135 |
| 510k Number | K011135 |
| Device Name: | GSI AUDERA |
| Classification | Audiometer |
| Applicant | NICOLET BIOMEDICAL 6355 JOYCE DR. Golden, CO 80403 |
| Contact | David W Wagner |
| Correspondent | David W Wagner NICOLET BIOMEDICAL 6355 JOYCE DR. Golden, CO 80403 |
| Product Code | EWO |
| CFR Regulation Number | 874.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-13 |
| Decision Date | 2001-07-26 |
Trademark Results [GSI AUDERA]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GSI AUDERA 97164099 not registered Live/Pending |
Rhinometrics A/S 2021-12-09 |
 GSI AUDERA 79250418 not registered Dead/Abandoned |
Rhinometrics A/S 2018-12-04 |
 GSI AUDERA 79095765 4127359 Dead/Cancelled |
Rhinometrics A/S 2010-10-18 |
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