K943460 is an FDA 510(k) clearance for the PORTAREM 2000. This device is classified as a Calibrator, Hearing Aid / Earphone And Analysis Systems (Class II - Special Controls, product code ETW).
Submitted by Starkey Laboratories, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on October 21, 1994, 95 days after receiving the submission on July 18, 1994.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3310.
| 510(k) Number | K943460 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 18, 1994 |
| Decision Date | October 21, 1994 |
| Days to Decision | 95 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | ETW - Calibrator, Hearing Aid / Earphone And Analysis Systems |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.3310 |