FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
IN-THE-EAR HEARING AID, MODEL CE-3
K Number: K780309
·
Decision Feb 28, 1978
Classifications
1
FEI Numbers
117
Registration Numbers
117
Same Product Code
1366
Applicant Total
59
Review Days
5
Basic Information
- Device Name
- IN-THE-EAR HEARING AID, MODEL CE-3
- K Number
- K780309
- 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
- February 23, 1978
- Decision Date
- February 28, 1978
- 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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| K Number | Device Name | ||
|---|---|---|---|
| K030180 | CRESCENT TINNITUS RETAINING SOUND GENERATOR | Sep 17, 2003 | Substantially Equivalent |
| K970952 | PRECISE IMPRESSION KIT | May 2, 1997 | Substantially Equivalent |
| K964245 | PRECISE, TYNMPANETTE, AND XACTO IMPRESSION KITS | Feb 4, 1997 | Substantially Equivalent |
| K964340 | PORTAREM-3000, PFS-6000 | Jan 10, 1997 | Substantially Equivalent |
| 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 |
| K963519 | EUROLINE A-675 SERIS | Sep 27, 1996 | Substantially Equivalent |