FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
AUTOMATIC LENSOMETER
K Number: K936199
·
Decision Sep 28, 1994
Classifications
1
FEI Numbers
64
Registration Numbers
65
Same Product Code
15
Applicant Total
48
Review Days
273
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Basic Information
- Device Name
- AUTOMATIC LENSOMETER
- K Number
- K936199
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.1425
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Canon USA, Inc.
- Date Received
- December 29, 1993
- Decision Date
- September 28, 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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| K992606 | CANON LASER BLOOD FLOWMETER (CLBF) MODEL 100 | Jun 21, 2000 | Substantially Equivalent |
| K992547 | CANON X-RAY DIGITAL CAMERA, MODEL CXDI-22 | Oct 13, 1999 | Substantially Equivalent |
| K981556 | CANON X-RAY DIGITAL CAMERA CXDI-11 | Nov 4, 1998 | Substantially Equivalent |