K911726 is an FDA 510(k) clearance for the PROGRAMMABLE AUDITORY COMPARATOR, MODIFICATION. This device is classified as a Hearing Aid, Master (Class II - Special Controls, product code KHL).
Submitted by Bausch & Lomb, Inc. (Tucker, US). The FDA issued a Cleared decision on October 23, 1991, 195 days after receiving the submission on April 11, 1991.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3330.
| 510(k) Number | K911726 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 11, 1991 |
| Decision Date | October 23, 1991 |
| Days to Decision | 195 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | - |
| Product Code | KHL - Hearing Aid, Master |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.3330 |