PROGRAMMABLE AUDITORY COMPARATOR, MODIFICATION
FDA 510(k) clearance K911726 · decided 1991-10-23
Clearance details
- K-number
- K911726
- Device name
- PROGRAMMABLE AUDITORY COMPARATOR, MODIFICATION
- Applicant
- Bausch & Lomb, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-04-11
- Decision date
- 1991-10-23
- Days to decision
- 195 days
- Clearance type
- Traditional
- Product code
- KHL
- Device class
- 2
- Regulation number
- 874.3330
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Tucker, GA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| LORI HEARING AID SIMULATOR (K964080) | Lori Medical Laboratories, Inc. | 1997-01-08 |
| RESOUND DEMO. BEHIND-THE-EAR HRNG., MODEL DEMO BTE (K894019) | Resound Corp. | 1989-09-21 |
| VOROBA PROGRAMMABLE AUDITORY COMPARATOR (K860171) | Voroba Technologies Assoc. | 1986-05-02 |
| CRAIGWELL MASTER HEARING AID MHA (K854126) | Craigwell Electronics, Ltd. | 1986-01-16 |
| RIONET HEARING AID (K802812) | Kindel & Anderson | 1980-11-26 |
| MODEL FS1 (K790481) | Starkey Laboratories, Inc. | 1979-04-03 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
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| Akreos Posterior Chamber Intraocular Lens (IOL) (P060022/S035) | Bausch & Lomb, Inc. | 2025-07-09 |
| enVista® Hydrophobic Acrylic Intraocular Lens (IOL) (P910056/S060) | Bausch & Lomb, Inc. | 2025-06-18 |
| enVista hydrophobic acrylic intraocular lens (IOL), enVista toric hydrophobic acrylic intraocular lens (IOL), enVista As (P910056/S059) | Bausch & Lomb, Inc. | 2025-05-30 |
| enVista Envy hydrophobic acrylic intraocular lens (IOL), enVista Envy toric hydrophobic acrylic intraocular lens (IOL) (P240005/S004) | Bausch & Lomb, Inc. | 2025-05-30 |