The following data is part of a premarket notification filed by Starkey Laboratories, Inc. with the FDA for Portarem-3000, Pfs-6000.
| Device ID | K964340 |
| 510k Number | K964340 |
| Device Name: | PORTAREM-3000, PFS-6000 |
| Classification | Audiometer |
| Applicant | STARKEY LABORATORIES, INC. 6600-6700 WASHINGTON AVE.SOUTH Eden Prairie, MN 55344 |
| Contact | Rick Stromberg |
| Correspondent | Rick Stromberg STARKEY LABORATORIES, INC. 6600-6700 WASHINGTON AVE.SOUTH Eden Prairie, MN 55344 |
| Product Code | EWO |
| CFR Regulation Number | 874.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-31 |
| Decision Date | 1997-01-10 |
| Summary: | summary |