FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PROGRAMMABLE AUDITORY COMPARATOR, MODIFICATION
K Number: K911726
·
Decision Oct 23, 1991
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
6
Applicant Total
92
Review Days
195
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Basic Information
- Device Name
- PROGRAMMABLE AUDITORY COMPARATOR, MODIFICATION
- K Number
- K911726
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.3330
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Bausch & Lomb, Inc.
- Date Received
- April 11, 1991
- Decision Date
- October 23, 1991
- Product Code
- KHL
- 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 |
|---|---|---|---|
| KHL | Hearing Aid, Master | FDA class 2 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KHL), ordered by most recent decision date.
LORI HEARING AID SIMULATOR
FDA 510(k)
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RESOUND DEMO. BEHIND-THE-EAR HRNG., MODEL DEMO BTE
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VOROBA PROGRAMMABLE AUDITORY COMPARATOR
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CRAIGWELL MASTER HEARING AID MHA
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
RIONET HEARING AID
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
MODEL FS1
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
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| 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 |