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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Mesa Laboratories, Inc.. It received FDA 510(k) clearance on 2020-09-02 under 510(k) 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. The listed applicant is Mesa Laboratories, Inc.. The 510(k) number is K201765.

When did SmartHDM-510 System receive FDA 510(k) clearance?

SmartHDM-510 System received FDA 510(k) clearance on 2020-09-02, under 510(k) number K201765.

Who is the listed applicant for SmartHDM-510 System?

The FDA 510(k) record lists Mesa Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SmartHDM-510 System?

The FDA product code for SmartHDM-510 System is FIZ.

Other records listing Mesa Laboratories, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K191496TDS Standard Solution

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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