Dosis SAM
K-Number: K180410 · 2019-01-16
ApplicantDosis, Inc.
Decision Date2019-01-16
Product CodeMQS
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Dosis SAM is a medical device manufactured by Dosis, Inc.. It received FDA 510(k) clearance on 2019-01-16 under approval number K180410. The device is classified under product code MQS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Dosis SAM?
Dosis SAM is a medical device that received FDA 510(k) clearance on 2019-01-16. It is manufactured by Dosis, Inc.. The 510(k) number is K180410.
When was Dosis SAM approved by the FDA?
Dosis SAM received FDA 510(k) clearance on 2019-01-16, under approval number K180410.
What company makes Dosis SAM?
Dosis SAM is manufactured by Dosis, Inc..
What is the FDA product code for Dosis SAM?
The FDA product code for Dosis SAM is MQS.
Related Devices (Code: MQS)
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.