TEETHAN 2.0
K-Number: K161716 · 2016-12-21
ApplicantBts S.P.A.
Decision Date2016-12-21
Product CodeKZM
Advisory CommitteePM
DecisionSubstantially Equivalent
Device Summary
TEETHAN 2.0 is the device name listed in this FDA 510(k) record. The listed applicant is Bts S.P.A.. It received FDA 510(k) clearance on 2016-12-21 under 510(k) number K161716. The device is classified under product code KZM. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the TEETHAN 2.0?
TEETHAN 2.0 is a medical device that received FDA 510(k) clearance on 2016-12-21. The listed applicant is Bts S.P.A.. The 510(k) number is K161716.
When did TEETHAN 2.0 receive FDA 510(k) clearance?
TEETHAN 2.0 received FDA 510(k) clearance on 2016-12-21, under 510(k) number K161716.
Who is the listed applicant for TEETHAN 2.0?
The FDA 510(k) record lists Bts S.P.A. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for TEETHAN 2.0?
The FDA product code for TEETHAN 2.0 is KZM.
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.