FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PLAYTONE AUDIOMETER
K Number: K872042
·
Decision Aug 11, 1987
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
234
Applicant Total
4
Review Days
76
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Basic Information
- Device Name
- PLAYTONE AUDIOMETER
- K Number
- K872042
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.1050
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Sensory Aids Corp.
- Date Received
- May 27, 1987
- Decision Date
- August 11, 1987
- Product Code
- EWO
- 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 |
|---|---|---|---|
| EWO | Audiometer | FDA class 2 | Ear, Nose, Throat |
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