FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Multiflex Tinnitus Technology
K Number: K201370
·
Decision Jun 19, 2020
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
76
Applicant Total
60
Review Days
28
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Basic Information
- Device Name
- Multiflex Tinnitus Technology
- K Number
- K201370
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 874.3400
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Starkey Laboratories, Inc.
- Date Received
- May 22, 2020
- Decision Date
- June 19, 2020
- Product Code
- KLW
- 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 |
|---|---|---|---|
| KLW | Masker, Tinnitus | FDA class 2 | Ear, Nose, Throat |
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Other Clearances by Starkey Laboratories, Inc.
| 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 |