FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SOUNDCHOICE K-AMP
K Number: K923735
·
Decision Sep 28, 1992
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
1366
Applicant Total
92
Review Days
63
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- SOUNDCHOICE K-AMP
- K Number
- K923735
- 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
- Bausch & Lomb, Inc.
- Date Received
- July 27, 1992
- Decision Date
- September 28, 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ESD), ordered by most recent decision date.
Lyric4 Hearing Aid
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
LYRIC2
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
LYRIC HEARING AID
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
INSOUND XT SERIES HEARING AID
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
SONIC INNOVATIONS COMPLETELY-IN-THE-CANAL DSP HEARING AID WITH SOFT SHELL
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
Other Clearances by Bausch & Lomb, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K192005 | Bausch + Lomb PreVue Inserter for enVista Preloaded | Oct 4, 2019 | Substantially Equivalent |
| K173480 | Crystalsert Lens Delivery System | Dec 11, 2017 | Substantially Equivalent |
| K151102 | Bausch + Lomb Injector System | May 22, 2015 | Substantially Equivalent |
| K131208 | BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS, BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS FOR PRESBYOPIA, | Sep 11, 2013 | Substantially Equivalent |
| K122575 | BAUSCH & LOMB PUREVISION (BALAFILCON A) VISIBILITY TINTED CONTACT LENS, BAUSCH & LOMB PUREVISION TORIC (BALAFILCON A) VI | Dec 20, 2012 | Substantially Equivalent |
| K113852 | BAUSCH & LOMB IOL INJECTOR | Sep 28, 2012 | Substantially Equivalent |
| K112909 | OCD04 3% HYDROGEN PEROXIDE CLEANING AND DISINFECTING SOULTION | Apr 30, 2012 | Substantially Equivalent |
| K111877 | EZS05 CLEANING AND DISINFECTING SOLUTION, BAUSCH + LOMB EZS05 CLEANING AND DISINFECTING SOLUTION | Jan 24, 2012 | Substantially Equivalent |
| K112192 | NATURELLE DAILY DISPOSABLE (HILAFILCON B) COSMETICALLY TINTED CONTACT LENS | Oct 25, 2011 | Substantially Equivalent |
| K101325 | STELLARIS PC VISION ENHANCEMENT SYSTEM | Aug 17, 2010 | Substantially Equivalent |