The following data is part of a premarket notification filed by Resound Corp. with the FDA for Resound Real Ear Loudness Mapping (relm) System.
| Device ID | K960229 |
| 510k Number | K960229 |
| Device Name: | RESOUND REAL EAR LOUDNESS MAPPING (RELM) SYSTEM |
| Classification | Calibrator, Hearing Aid / Earphone And Analysis Systems |
| 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 | ETW |
| CFR Regulation Number | 874.3310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-01-17 |
| Decision Date | 1996-03-07 |
| Summary: | summary |