FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
OPTIEAR
K Number: K920322
·
Decision Apr 23, 1992
Classifications
1
FEI Numbers
228
Registration Numbers
228
Same Product Code
55
Applicant Total
1
Review Days
90
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Basic Information
- Device Name
- OPTIEAR
- K Number
- K920322
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.4770
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Nankivell Industries, Inc.
- Date Received
- January 24, 1992
- Decision Date
- April 23, 1992
- Product Code
- ERA
- 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 |
|---|---|---|---|
| ERA | Otoscope | FDA class 1 | Ear, Nose, Throat |
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