ZEISS INFRARED 800 WITH FLOW 800 OPTION
FDA 510(k) clearance K100468 · decided 2010-03-03
Clearance details
- K-number
- K100468
- Device name
- ZEISS INFRARED 800 WITH FLOW 800 OPTION
- Applicant
- Carl Zeiss Surgical GmbH
- Decision
- Substantially Equivalent
- Date received
- 2010-02-18
- Decision date
- 2010-03-03
- Days to decision
- 13 days
- Clearance type
- Traditional
- Product code
- IZI
- Device class
- 2
- Regulation number
- 892.1600
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Dublin, CA, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.