FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HAND KERATOSCOPE
K Number: K821080
·
Decision May 24, 1982
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
6
Applicant Total
13
Review Days
35
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Basic Information
- Device Name
- HAND KERATOSCOPE
- K Number
- K821080
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.1350
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Medical Equipment Designs, Inc.
- Date Received
- April 19, 1982
- Decision Date
- May 24, 1982
- Product Code
- HLR
- 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 |
|---|---|---|---|
| HLR | Keratoscope, Battery-Powered | FDA class 1 | Ophthalmic |
Similar 510(k) Clearances
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JEDMED/POLACK KERATOSCOPE HS/SL
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PLACIDO DISC
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KARICKHOFF KERATOSCOPE
FDA 510(k)
FDA Class 1
·Ophthalmic
Other Clearances by Medical Equipment Designs, Inc.
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|---|---|---|---|
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| K894152 | MEDITHERM | Jun 11, 1990 | Substantially Equivalent |
| K895375 | MULTISPIRO | Nov 27, 1989 | Substantially Equivalent |
| K851277 | MICROSPIRO-SDS | Apr 19, 1985 | Substantially Equivalent |
| K840908 | CHESTAC-25F SPIROMETER | May 14, 1984 | Substantially Equivalent |
| K840929 | FRC 85 SERIES SPIROMETER | May 14, 1984 | Substantially Equivalent |
| K821081 | CHART PROJECTOR | Jun 14, 1982 | Substantially Equivalent |
| K821084 | UNIVERSAL TRIAL FRAMEE | Jun 14, 1982 | Substantially Equivalent |
| K821107 | EXOPHTHALMOMETER | Jun 14, 1982 | Substantially Equivalent |
| K821083 | P.D. METER | Jun 14, 1982 | Substantially Equivalent |