FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EXOPHTHALMOMETER
K Number: K821107
·
Decision Jun 14, 1982
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
7
Applicant Total
13
Review Days
55
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Basic Information
- Device Name
- EXOPHTHALMOMETER
- K Number
- K821107
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1570
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Medical Equipment Designs, Inc.
- Date Received
- April 20, 1982
- Decision Date
- June 14, 1982
- Product Code
- HCS
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| HCS | Device, Temperature Measurement, Direct Contact, Powered | FDA class 2 | Neurology |
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|---|---|---|---|
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| 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 |
| K821083 | P.D. METER | Jun 14, 1982 | Substantially Equivalent |
| K821082 | TRIAL LENS SET | Jun 14, 1982 | Substantially Equivalent |