FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HUMPHREY FIELD ANALYZER (HFA II)
K Number: K954167
·
Decision Nov 24, 1995
Classifications
1
FEI Numbers
66
Registration Numbers
67
Same Product Code
40
Applicant Total
44
Review Days
80
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Basic Information
- Device Name
- HUMPHREY FIELD ANALYZER (HFA II)
- K Number
- K954167
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.1605
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Carl Zeiss, Inc.
- Date Received
- September 5, 1995
- Decision Date
- November 24, 1995
- Product Code
- HPT
- 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 |
|---|---|---|---|
| HPT | Perimeter, Automatic, Ac-Powered | FDA class 1 | Ophthalmic |
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| K961171 | HUMPHREY OCT SCANNER | Jun 21, 1996 | Substantially Equivalent |
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| K950985 | ZEISS ENDOLIVE STERO ENDOSCOPE | Mar 29, 1995 | Substantially Equivalent |
| K931478 | ZEISS OPMI L STEREO-LAPAROSCOPE | Sep 28, 1994 | Substantially Equivalent |