FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Z-BOX
K Number: K030764
·
Decision Apr 24, 2003
Classifications
1
FEI Numbers
250
Registration Numbers
250
Same Product Code
422
Applicant Total
5
Review Days
44
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Basic Information
- Device Name
- Z-BOX
- K Number
- K030764
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 882.4560
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Z-Kat, Inc.
- Date Received
- March 11, 2003
- Decision Date
- April 24, 2003
- 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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Other Clearances by Z-Kat, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K023975 | VOYAGER LINUX | Dec 20, 2002 | Substantially Equivalent |
| K013025 | MODIFICATION TO FLOUROLAB PLUS | Oct 3, 2001 | Substantially Equivalent |
| K002893 | FLUOROLAB PLUS | Dec 4, 2000 | Substantially Equivalent |
| K984298 | Z KAT FLUROTACTIC GUIDANCE SYSTEM MKI | Jun 23, 1999 | Substantially Equivalent |