FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VISULINK 900 ARGON
K Number: K952894
·
Decision Aug 14, 1995
Classifications
1
FEI Numbers
61
Registration Numbers
62
Same Product Code
176
Applicant Total
44
Review Days
52
Basic Information
- Device Name
- VISULINK 900 ARGON
- K Number
- K952894
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.4390
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- CARL ZEISS, INC.
- Date Received
- June 23, 1995
- Decision Date
- August 14, 1995
- Product Code
- HQF
- 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 |
|---|---|---|---|
| HQF | Laser, Ophthalmic | FDA class 2 | Ophthalmic |
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Other Clearances by CARL ZEISS, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K013402 | VISULAS 532S | Nov 14, 2001 | Substantially Equivalent |
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| K993357 | IOLMASTER | Mar 20, 2000 | Substantially Equivalent |
| K983868 | OPMI TWINER SURGICAL MICROSCOPE | Jan 29, 1999 | Substantially Equivalent |
| K965139 | SURGICAL MICROSCOPE NAVIGATOR (SMN) SYSTEM/SURGICAL TOOL NAVIGATOR (STN) SYSTEM | Apr 23, 1997 | Substantially Equivalent |
| K961380 | CPC PROBE | Mar 17, 1997 | Substantially Equivalent |
| K961171 | HUMPHREY OCT SCANNER | Jun 21, 1996 | Substantially Equivalent |
| K954167 | HUMPHREY FIELD ANALYZER (HFA II) | Nov 24, 1995 | Substantially Equivalent |
| K950985 | ZEISS ENDOLIVE STERO ENDOSCOPE | Mar 29, 1995 | Substantially Equivalent |
| K931478 | ZEISS OPMI L STEREO-LAPAROSCOPE | Sep 28, 1994 | Substantially Equivalent |