FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
STARKEY MODEL P1 MODULE
K Number: K873031
·
Decision Feb 8, 1988
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
23
Applicant Total
60
Review Days
188
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Basic Information
- Device Name
- STARKEY MODEL P1 MODULE
- K Number
- K873031
- 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
- August 4, 1987
- Decision Date
- February 8, 1988
- Product Code
- LRB
- 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 |
|---|---|---|---|
| LRB | Face Plate Hearing Aid | FDA class 1 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LRB), ordered by most recent decision date.
FACEPLATE ASSEMBLY
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
INTRASTAR PRE-WIRED FACEPLATE FOR IN-THE-EAR HEARING AIDS
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
MODULE PROGRAM
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
AUDINA PREWIRES (FACEPLATE HEARING AID SERIES)
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
ARTISAN PROGRAMMER & HEARING AID
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
SILVER LD MODULE, ITE
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
Other Clearances by Starkey Laboratories, Inc.
| 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 |