FDA 510(k)
FDA class 1
Substantially Equivalent
🇮🇱 Israel
THROAT-A-SCOPE
K Number: K923227
·
Decision Dec 4, 1992
Classifications
1
FEI Numbers
96
Registration Numbers
96
Same Product Code
48
Applicant Total
4
Review Days
156
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Basic Information
- Device Name
- THROAT-A-SCOPE
- K Number
- K923227
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.4350
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Truphatek, Ltd.
- Date Received
- July 1, 1992
- Decision Date
- December 4, 1992
- Product Code
- EQH
- 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 |
|---|---|---|---|
| EQH | Source, Carrier, Fiberoptic Light | FDA class 1 | Ear, Nose, Throat |
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