Cardiac Monitor 1500
K-Number: K191697 · 2020-02-21
ApplicantZynex Medical, Inc.
Decision Date2020-02-21
Product CodeDSB
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Cardiac Monitor 1500 is a medical device manufactured by Zynex Medical, Inc.. It received FDA 510(k) clearance on 2020-02-21 under approval number K191697. The device is classified under product code DSB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Cardiac Monitor 1500?
Cardiac Monitor 1500 is a medical device that received FDA 510(k) clearance on 2020-02-21. It is manufactured by Zynex Medical, Inc.. The 510(k) number is K191697.
When was Cardiac Monitor 1500 approved by the FDA?
Cardiac Monitor 1500 received FDA 510(k) clearance on 2020-02-21, under approval number K191697.
What company makes Cardiac Monitor 1500?
Cardiac Monitor 1500 is manufactured by Zynex Medical, Inc..
What is the FDA product code for Cardiac Monitor 1500?
The FDA product code for Cardiac Monitor 1500 is DSB.
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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.