The following data is part of a premarket notification filed by Insound Medical Inc. with the FDA for Insound Xt Series Hearing Aid.
| Device ID | K021867 |
| 510k Number | K021867 |
| Device Name: | INSOUND XT SERIES HEARING AID |
| Classification | Hearing Aid, Air Conduction |
| Applicant | INSOUND MEDICAL INC. 37500 CENTRAL COURT Newark, CA 94560 |
| Contact | Susan Whichard |
| Correspondent | Susan Whichard INSOUND MEDICAL INC. 37500 CENTRAL COURT Newark, CA 94560 |
| Product Code | ESD |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-06 |
| Decision Date | 2002-11-19 |
| Summary: | summary |