FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CALIPER-OPTHALMIC
K Number: K813315
·
Decision Mar 1, 1982
Classifications
1
FEI Numbers
162
Registration Numbers
162
Same Product Code
6
Applicant Total
3
Review Days
97
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Basic Information
- Device Name
- CALIPER-OPTHALMIC
- K Number
- K813315
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4350
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Design Research Assoc., Inc.
- Date Received
- November 24, 1981
- Decision Date
- March 1, 1982
- Product Code
- HOE
- 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 |
|---|---|---|---|
| HOE | Caliper, Ophthalmic | FDA class 1 | Ophthalmic |
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