FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FIBEROPTIC LIGHTSOURCES AND CARRIERS
K Number: K933145
·
Decision Sep 7, 1993
Classifications
1
FEI Numbers
96
Registration Numbers
96
Same Product Code
48
Applicant Total
3
Review Days
71
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Basic Information
- Device Name
- FIBEROPTIC LIGHTSOURCES AND CARRIERS
- K Number
- K933145
- 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
- Electro Fiberoptics Corp.
- Date Received
- June 28, 1993
- Decision Date
- September 7, 1993
- 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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