K964340 is an FDA 510(k) clearance for the PORTAREM-3000, PFS-6000. This device is classified as a Audiometer (Class II - Special Controls, product code EWO).
Submitted by Starkey Laboratories, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on January 10, 1997, 71 days after receiving the submission on October 31, 1996.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.1050.
| 510(k) Number | K964340 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 31, 1996 |
| Decision Date | January 10, 1997 |
| Days to Decision | 71 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | EWO - Audiometer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.1050 |