FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BRIMFIELD FIBEROPTIC LIGHT SCOURCE
K Number: K841731
·
Decision Jul 16, 1984
Classifications
1
FEI Numbers
96
Registration Numbers
96
Same Product Code
48
Applicant Total
5
Review Days
81
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Basic Information
- Device Name
- BRIMFIELD FIBEROPTIC LIGHT SCOURCE
- K Number
- K841731
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.4350
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Brimfield Scientific Instruments
- Date Received
- April 26, 1984
- Decision Date
- July 16, 1984
- 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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Other Clearances by Brimfield Scientific Instruments
| K Number | Device Name | ||
|---|---|---|---|
| K852042 | BRIMFIELD CANNULATED BLADE HOLDER | Jun 11, 1985 | Substantially Equivalent |
| K843135 | BRIMFIELD CANNULATED MAGNETIC RETRIEVER | Sep 26, 1984 | Substantially Equivalent |
| K843136 | BRIMFIELD CANNULATED GRASPING HOOKS | Sep 25, 1984 | Substantially Equivalent |
| K832147 | CIRCUT 1 | Jul 26, 1983 | Substantially Equivalent |