INSTATRAK
FDA 510(k) clearance K960330 · decided 1996-04-08
Clearance details
- K-number
- K960330
- Device name
- INSTATRAK
- Applicant
- Visualization Technology, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-01-24
- Decision date
- 1996-04-08
- Days to decision
- 75 days
- Clearance type
- Traditional
- Product code
- LLZ
- Device class
- 2
- Regulation number
- 892.2050
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Woburn, MA, US
- Third-party review
- No
- Expedited review
- No
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