510(k) K964080
- Device
- LORI HEARING AID SIMULATOR
- Applicant
- LORI MEDICAL LABORATORIES, INC.
- 510(k) number
- K964080
- Product code
- KHL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-01-08
- Date received
- 1996-10-11
- Regulation
- 874.3330
- Classification name
- Hearing Aid, Master
- Medical specialty
- Ear Nose & Throat
- Review panel
- Ear Nose & Throat
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- GARY R MAAS
- Address
- 696 Mendelssohn Ave. N. Golden Valley MN US 55427 55427
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KHL #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K911726 | PROGRAMMABLE AUDITORY COMPARATOR, MODIFICATION | Bausch & Lomb, Inc. | 1991-10-23 |
| K894019 | RESOUND DEMO. BEHIND-THE-EAR HRNG., MODEL DEMO BTE | Resound Corp. | 1989-09-21 |
| K860171 | VOROBA PROGRAMMABLE AUDITORY COMPARATOR | Voroba Technologies Assoc. | 1986-05-02 |
| K854126 | CRAIGWELL MASTER HEARING AID MHA | Craigwell Electronics, Ltd. | 1986-01-16 |
| K802812 | RIONET HEARING AID | Kindel & Anderson | 1980-11-26 |
| K790481 | MODEL FS1 | Starkey Laboratories, Inc. | 1979-04-03 |
Legacy Summary#
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FDA Review#
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