510(k) K854126
- Device
- CRAIGWELL MASTER HEARING AID MHA
- Applicant
- CRAIGWELL ELECTRONICS, LTD.
- 510(k) number
- K854126
- Product code
- KHL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-01-16
- Date received
- 1985-10-09
- Regulation
- 874.3330
- Classification name
- Hearing Aid, Master
- Medical specialty
- Ear Nose & Throat
- Review panel
- Ear Nose & Throat
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- WELLBURN
- Address
- Meadow Vale House Lower Blunsdon, Nr Swindon Wiltshire Sn2 4bj GB
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KHL #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K964080 | LORI HEARING AID SIMULATOR | Lori Medical Laboratories, Inc. | 1997-01-08 |
| 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 |
| 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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