The following data is part of a premarket notification filed by Resound Corp. with the FDA for Resound Portable Prescriptive Programming System.
| Device ID | K912669 |
| 510k Number | K912669 |
| Device Name: | RESOUND PORTABLE PRESCRIPTIVE PROGRAMMING SYSTEM |
| Classification | Audiometer |
| Applicant | RESOUND CORP. 220 SAGINAW DRIVE, SEAPORT CENTRE Redwood City, CA 94063 |
| Contact | Jeannette Johnson |
| Correspondent | Jeannette Johnson RESOUND CORP. 220 SAGINAW DRIVE, SEAPORT CENTRE Redwood City, CA 94063 |
| Product Code | EWO |
| CFR Regulation Number | 874.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-18 |
| Decision Date | 1991-09-16 |