FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ITC-ITE TYPE HEAR AID/HEAR-O-INC MDL FAVORITE EAR
K Number: K882721
·
Decision Sep 15, 1988
Classifications
1
FEI Numbers
117
Registration Numbers
117
Same Product Code
1366
Applicant Total
1
Review Days
76
Basic Information
- Device Name
- ITC-ITE TYPE HEAR AID/HEAR-O-INC MDL FAVORITE EAR
- K Number
- K882721
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.3300
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- HEAR-O INC. C/O L.P. LEALE & ASSOC.
- Date Received
- July 1, 1988
- Decision Date
- September 15, 1988
- 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 |
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