T-SHAPE 2
K-Number: K231092 · 2023-09-22
ApplicantB&M S.R.L. Marketing Nel Benessere
Decision Date2023-09-22
Product CodeNUV
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
T-SHAPE 2 is a medical device manufactured by B&M S.R.L. Marketing Nel Benessere. It received FDA 510(k) clearance on 2023-09-22 under approval number K231092. The device is classified under product code NUV. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the T-SHAPE 2?
T-SHAPE 2 is a medical device that received FDA 510(k) clearance on 2023-09-22. It is manufactured by B&M S.R.L. Marketing Nel Benessere. The 510(k) number is K231092.
When was T-SHAPE 2 approved by the FDA?
T-SHAPE 2 received FDA 510(k) clearance on 2023-09-22, under approval number K231092.
What company makes T-SHAPE 2?
T-SHAPE 2 is manufactured by B&M S.R.L. Marketing Nel Benessere.
What is the FDA product code for T-SHAPE 2?
The FDA product code for T-SHAPE 2 is NUV.
Related Devices (Code: NUV)
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.