FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AUDITORY TRAINER
K Number: K771671
·
Decision Sep 12, 1977
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
31
Applicant Total
1
Review Days
11
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Basic Information
- Device Name
- AUDITORY TRAINER
- K Number
- K771671
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.3320
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Accutone, Inc.
- Date Received
- September 1, 1977
- Decision Date
- September 12, 1977
- Product Code
- EPF
- 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 |
|---|---|---|---|
| EPF | Hearing Aid, Group And Auditory Trainer | FDA class 2 | Ear, Nose, Throat |
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