FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SURGICAL MICROSCOPE NAVIGATOR (SMN) SYSTEM/SURGICAL TOOL NAVIGATOR (STN) SYSTEM
K Number: K965139
·
Decision Apr 23, 1997
Classifications
1
FEI Numbers
250
Registration Numbers
250
Same Product Code
422
Applicant Total
44
Review Days
121
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Basic Information
- Device Name
- SURGICAL MICROSCOPE NAVIGATOR (SMN) SYSTEM/SURGICAL TOOL NAVIGATOR (STN) SYSTEM
- K Number
- K965139
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4560
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Carl Zeiss, Inc.
- Date Received
- December 23, 1996
- Decision Date
- April 23, 1997
- Product Code
- HAW
- 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 |
|---|---|---|---|
| HAW | Neurological Stereotaxic Instrument | FDA class 2 | Neurology |
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| K961171 | HUMPHREY OCT SCANNER | Jun 21, 1996 | Substantially Equivalent |
| K954167 | HUMPHREY FIELD ANALYZER (HFA II) | Nov 24, 1995 | Substantially Equivalent |
| K952894 | VISULINK 900 ARGON | Aug 14, 1995 | Substantially Equivalent |
| K950985 | ZEISS ENDOLIVE STERO ENDOSCOPE | Mar 29, 1995 | Substantially Equivalent |
| K931478 | ZEISS OPMI L STEREO-LAPAROSCOPE | Sep 28, 1994 | Substantially Equivalent |