FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MODEL WC-3 HEARING AID
K Number: K790651
·
Decision Apr 10, 1979
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
1366
Applicant Total
60
Review Days
7
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Basic Information
- Device Name
- MODEL WC-3 HEARING AID
- K Number
- K790651
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.3300
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Starkey Laboratories, Inc.
- Date Received
- April 3, 1979
- Decision Date
- April 10, 1979
- Product Code
- ESD
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| ESD | Hearing Aid, Air-Conduction, Prescription | FDA class 1 | Ear, Nose, Throat |
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|---|---|---|---|
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| K970952 | PRECISE IMPRESSION KIT | May 2, 1997 | Substantially Equivalent |
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| K964216 | STARKEY TM-3, TM-5 HIGH FREQUENCY TINNITUS MASKER | Dec 6, 1996 | Substantially Equivalent |
| K964214 | STARKEY A-13 SEQUEL PROGRAMMABLE, A-13 K-AMP PROGRAMMABLE AIR CONDUCTION HEARING AIDS | Nov 27, 1996 | Substantially Equivalent |
| K964244 | STARKEY CUSTOM SEQUEL PROGRAMMABLE AND K AMP PROGRAMMABLE AIR CONDUCTION HEARING AIDS | Nov 27, 1996 | Substantially Equivalent |
| K963838 | STARKEY TM AIR CONDUCTION TINNITUS MASKER | Nov 26, 1996 | Substantially Equivalent |
| K963995 | STARKEY MA-3 AIR CONDUCTION COMBINATION HEARING AID/TINNITUS MASKER | Nov 26, 1996 | Substantially Equivalent |