FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
STARKEY SM SERIES BTE HEARING AIDS
K Number: K923784
·
Decision Aug 26, 1992
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
1366
Applicant Total
60
Review Days
29
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Basic Information
- Device Name
- STARKEY SM SERIES BTE HEARING AIDS
- K Number
- K923784
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.3300
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Starkey Laboratories, Inc.
- Date Received
- July 28, 1992
- Decision Date
- August 26, 1992
- 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 | ||
|---|---|---|---|
| K201370 | Multiflex Tinnitus Technology | Jun 19, 2020 | Substantially Equivalent |
| 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 |