FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BLEPHAROMETER
K Number: K801937
·
Decision Sep 16, 1980
Classifications
1
FEI Numbers
162
Registration Numbers
162
Same Product Code
6
Applicant Total
5
Review Days
35
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Basic Information
- Device Name
- BLEPHAROMETER
- K Number
- K801937
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4350
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Aztec Medical Products, Inc.
- Date Received
- August 12, 1980
- Decision Date
- September 16, 1980
- 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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