FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
STARKEY LABORATORIES OTOSCOPE
K Number: K922752
·
Decision Sep 4, 1992
Classifications
1
FEI Numbers
228
Registration Numbers
228
Same Product Code
55
Applicant Total
60
Review Days
88
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Basic Information
- Device Name
- STARKEY LABORATORIES OTOSCOPE
- K Number
- K922752
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.4770
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Starkey Laboratories, Inc.
- Date Received
- June 8, 1992
- Decision Date
- September 4, 1992
- Product Code
- ERA
- 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 |
|---|---|---|---|
| ERA | Otoscope | FDA class 1 | Ear, Nose, Throat |
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WELCH ALLY OTOSCOPE
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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 |