FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LOW-POWER BINOCULAR LOUPE
K Number: K875124
·
Decision Feb 19, 1988
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
2
Applicant Total
1
Review Days
66
Basic Information
- Device Name
- LOW-POWER BINOCULAR LOUPE
- K Number
- K875124
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4770
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- SEILER INSTRUMENT & MFG. CO., INC.
- Date Received
- December 15, 1987
- Decision Date
- February 19, 1988
- Product Code
- HOH
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- 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 |
|---|---|---|---|
| HOH | Spectacle, Operating (Loupe), Ophthalmic | FDA class 1 | Ophthalmic |
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