FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SOLA SCHULTZE-CROCK OPTHALMOSCOPE
K Number: K760771
·
Decision Oct 15, 1976
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
46
Applicant Total
152
Review Days
11
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Basic Information
- Device Name
- SOLA SCHULTZE-CROCK OPTHALMOSCOPE
- K Number
- K760771
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.1570
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Codman & Shurtleff, Inc.
- Date Received
- October 4, 1976
- Decision Date
- October 15, 1976
- Product Code
- HLJ
- 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 |
|---|---|---|---|
| HLJ | Ophthalmoscope, Battery-Powered | FDA class 2 | Ophthalmic |
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