The following data is part of a premarket notification filed by Tympany, Inc. with the FDA for Otogram.
| Device ID | K041853 |
| 510k Number | K041853 |
| Device Name: | OTOGRAM |
| Classification | Calibrator, Hearing Aid / Earphone And Analysis Systems |
| Applicant | TYMPANY, INC. PO BOX 7007 Deerfield, IL 60015 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm TYMPANY, INC. PO BOX 7007 Deerfield, IL 60015 |
| Product Code | ETW |
| CFR Regulation Number | 874.3310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-07-08 |
| Decision Date | 2004-09-03 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() OTOGRAM 85128511 4290819 Dead/Cancelled |
OTOTRONIX, LLC 2010-09-13 |
![]() OTOGRAM 77531454 not registered Dead/Abandoned |
Tympany, LLC 2008-07-25 |
![]() OTOGRAM 76427326 not registered Dead/Abandoned |
Tympany, Inc. 2002-07-02 |
![]() OTOGRAM 73056418 1049527 Dead/Cancelled |
Shalako International, Inc. 0000-00-00 |