The following data is part of a premarket notification filed by Resound Corp. with the FDA for Audallion Ii Hearing System.
| Device ID | K970215 |
| 510k Number | K970215 |
| Device Name: | AUDALLION II HEARING SYSTEM |
| Classification | Hearing Aid, Air Conduction |
| Applicant | RESOUND CORP. 220 SAGINAW DRIVE, SEAPORT CENTRE Redwood City, CA 94063 |
| Contact | Krista M Buckles |
| Correspondent | Krista M Buckles RESOUND CORP. 220 SAGINAW DRIVE, SEAPORT CENTRE Redwood City, CA 94063 |
| Product Code | ESD |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-21 |
| Decision Date | 1997-03-31 |
| Summary: | summary |