XN CAL
K-Number: K160585 · 2016-12-22
ApplicantStreck
Decision Date2016-12-22
Product CodeKRX
Advisory CommitteeHE
DecisionSubstantially Equivalent
Device Summary
XN CAL is a medical device manufactured by Streck. It received FDA 510(k) clearance on 2016-12-22 under approval number K160585. The device is classified under product code KRX. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the XN CAL?
XN CAL is a medical device that received FDA 510(k) clearance on 2016-12-22. It is manufactured by Streck. The 510(k) number is K160585.
When was XN CAL approved by the FDA?
XN CAL received FDA 510(k) clearance on 2016-12-22, under approval number K160585.
What company makes XN CAL?
XN CAL is manufactured by Streck.
What is the FDA product code for XN CAL?
The FDA product code for XN CAL is KRX.
Other Devices by Streck
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.