FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LTS CORNEAL MICROSCOPE LASER TOMOGRAPHIC SCANNER
K Number: K864369
·
Decision Dec 15, 1986
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
4
Applicant Total
1
Review Days
40
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Basic Information
- Device Name
- LTS CORNEAL MICROSCOPE LASER TOMOGRAPHIC SCANNER
- K Number
- K864369
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.1450
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Heidelberg Instruments
- Date Received
- November 5, 1986
- Decision Date
- December 15, 1986
- Product Code
- HJB
- 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 |
|---|---|---|---|
| HJB | Instrument, Measuring, Corneal Radius | FDA class 1 | Ophthalmic |
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