FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
VIDEOTOSCOPE
K Number: K943916
·
Decision Aug 25, 1994
Classifications
1
FEI Numbers
228
Registration Numbers
228
Same Product Code
55
Applicant Total
111
Review Days
14
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Basic Information
- Device Name
- VIDEOTOSCOPE
- K Number
- K943916
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.4770
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Welch Allyn, Inc.
- Date Received
- August 11, 1994
- Decision Date
- August 25, 1994
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ERA), ordered by most recent decision date.
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OSRAM ITOS
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OPTUS OTOSCOPES
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WELCH ALLYN BI-OTOSCOPE
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
WELCH ALLY OTOSCOPE
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
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