XN CAL
K-Number: K160585 · 2016-12-22
ApplicantStreck
Decision Date2016-12-22
Product CodeKRX
Advisory CommitteeHE
DecisionSubstantially Equivalent
Device Summary
XN CAL is the device name listed in this FDA 510(k) record. The listed applicant is Streck. It received FDA 510(k) clearance on 2016-12-22 under 510(k) 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. The listed applicant is Streck. The 510(k) number is K160585.
When did XN CAL receive FDA 510(k) clearance?
XN CAL received FDA 510(k) clearance on 2016-12-22, under 510(k) number K160585.
Who is the listed applicant for XN CAL?
The FDA 510(k) record lists Streck as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for XN CAL?
The FDA product code for XN CAL is KRX.
Other records listing Streck as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Official Source
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