The following data is part of a premarket notification filed by Oticon Corp. with the FDA for Custom In-the-canal (itc) Hearing Aid Model I54.
| Device ID | K895140 |
| 510k Number | K895140 |
| Device Name: | CUSTOM IN-THE-CANAL (ITC) HEARING AID MODEL I54 |
| Classification | Hearing Aid, Air Conduction |
| Applicant | OTICON CORP. 29 SCHOOLHOUSE RD. P.O. BOX 6724 Somerset, NJ 08873 |
| Contact | Robert Martin |
| Correspondent | Robert Martin OTICON CORP. 29 SCHOOLHOUSE RD. P.O. BOX 6724 Somerset, NJ 08873 |
| Product Code | ESD |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-16 |
| Decision Date | 1989-10-11 |