EX3 STEPPER, CLASSIC STEPPER, MULTI-PURPOSE WORKSTATION STEPPER; MICRO-TOUCH, MICRO-TOUCH LP, MULIT-PURPOSE WORKSTATION,
FDA 510(k) clearance K131161 · decided 2013-09-17
Clearance details
- K-number
- K131161
- Device name
- EX3 STEPPER, CLASSIC STEPPER, MULTI-PURPOSE WORKSTATION STEPPER; MICRO-TOUCH, MICRO-TOUCH LP, MULIT-PURPOSE WORKSTATION,
- Applicant
- CIVCO Medical Instruments Co., Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-04-24
- Decision date
- 2013-09-17
- Days to decision
- 146 days
- Clearance type
- Traditional
- Product code
- ITX
- Device class
- 2
- Regulation number
- 892.1570
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Kalona, IA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.