FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TECHNOMED C-SCAN COLOR ELLIPSOID TOPOMETER
K Number: K945382
·
Decision Jan 31, 1995
Classifications
1
FEI Numbers
17
Registration Numbers
18
Same Product Code
28
Applicant Total
2
Review Days
90
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Basic Information
- Device Name
- TECHNOMED C-SCAN COLOR ELLIPSOID TOPOMETER
- K Number
- K945382
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.1350
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Expertech Assoc., Inc.
- Date Received
- November 2, 1994
- Decision Date
- January 31, 1995
- Product Code
- HLQ
- 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 |
|---|---|---|---|
| HLQ | Keratoscope, Ac-Powered | FDA class 1 | Ophthalmic |
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Other Clearances by Expertech Assoc., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K962532 | RODENSTOCK SLITLAMP (MODEL 5000 & 4000) | Jul 25, 1996 | Substantially Equivalent |