ulrichINJECT CT motion
FDA 510(k) clearance K171392 · decided 2017-11-09
Clearance details
- K-number
- K171392
- Device name
- ulrichINJECT CT motion
- Applicant
- Ulrich GmbH & Co. KG
- Decision
- Substantially Equivalent
- Date received
- 2017-05-11
- Decision date
- 2017-11-09
- Days to decision
- 182 days
- Clearance type
- Traditional
- Product code
- IZQ
- Device class
- 2
- Regulation number
- 870.1650
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Ulm, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.