Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

PowerDot PD-01MT

K-Number: K181759 · 2018-11-09

Decision Date2018-11-09
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

PowerDot PD-01MT is a medical device manufactured by Smartmissimo Technologies Pte, Ltd.. It received FDA 510(k) clearance on 2018-11-09 under approval number K181759. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PowerDot PD-01MT?

PowerDot PD-01MT is a medical device that received FDA 510(k) clearance on 2018-11-09. It is manufactured by Smartmissimo Technologies Pte, Ltd.. The 510(k) number is K181759.

When was PowerDot PD-01MT approved by the FDA?

PowerDot PD-01MT received FDA 510(k) clearance on 2018-11-09, under approval number K181759.

What company makes PowerDot PD-01MT?

PowerDot PD-01MT is manufactured by Smartmissimo Technologies Pte, Ltd..

What is the FDA product code for PowerDot PD-01MT?

The FDA product code for PowerDot PD-01MT is IPF.

Other Devices by Smartmissimo Technologies Pte, Ltd.

Related Devices (Code: IPF)

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.