C-THV SYSTEM
FDA 510(k) clearance K113594 · decided 2012-03-02
Clearance details
- K-number
- K113594
- Device name
- C-THV SYSTEM
- Applicant
- Paieon, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-12-05
- Decision date
- 2012-03-02
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- IZI
- Device class
- 2
- Regulation number
- 892.1600
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Rosh Haayin, IL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.