FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NASOPHARYNGOSCOPE
K Number: K934422
·
Decision Jan 27, 1994
Classifications
1
FEI Numbers
132
Registration Numbers
132
Same Product Code
161
Applicant Total
3
Review Days
136
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Basic Information
- Device Name
- NASOPHARYNGOSCOPE
- K Number
- K934422
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.4760
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Marks & Murase
- Date Received
- September 13, 1993
- Decision Date
- January 27, 1994
- Product Code
- EOB
- 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 |
|---|---|---|---|
| EOB | Nasopharyngoscope (Flexible Or Rigid) | FDA class 2 | Ear, Nose, Throat |
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