FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LENSCHEK
K Number: K944022
·
Decision Nov 17, 1994
Classifications
1
FEI Numbers
64
Registration Numbers
65
Same Product Code
15
Applicant Total
3
Review Days
92
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Basic Information
- Device Name
- LENSCHEK
- K Number
- K944022
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.1425
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Leica, Inc.
- Date Received
- August 17, 1994
- Decision Date
- November 17, 1994
- Product Code
- HLM
- 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 |
|---|---|---|---|
| HLM | Instrument, Measuring, Lens, Ac-Powered | FDA class 1 | Ophthalmic |
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