SmartHDM-510 System
K-Number: K201765 · 2020-09-02
ApplicantMesa Laboratories, Inc.
Decision Date2020-09-02
Product CodeFIZ
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
SmartHDM-510 System is a medical device manufactured by Mesa Laboratories, Inc.. It received FDA 510(k) clearance on 2020-09-02 under approval number K201765. The device is classified under product code FIZ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SmartHDM-510 System?
SmartHDM-510 System is a medical device that received FDA 510(k) clearance on 2020-09-02. It is manufactured by Mesa Laboratories, Inc.. The 510(k) number is K201765.
When was SmartHDM-510 System approved by the FDA?
SmartHDM-510 System received FDA 510(k) clearance on 2020-09-02, under approval number K201765.
What company makes SmartHDM-510 System?
SmartHDM-510 System is manufactured by Mesa Laboratories, Inc..
What is the FDA product code for SmartHDM-510 System?
The FDA product code for SmartHDM-510 System is FIZ.
Other Devices by Mesa Laboratories, Inc.
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.