Comet-PLUS
K-Number: K172711 · 2017-11-03
Decision Date2017-11-03
Product CodeOLV
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Comet-PLUS is a medical device manufactured by Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek). It received FDA 510(k) clearance on 2017-11-03 under approval number K172711. The device is classified under product code OLV. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Comet-PLUS?
Comet-PLUS is a medical device that received FDA 510(k) clearance on 2017-11-03. It is manufactured by Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek). The 510(k) number is K172711.
When was Comet-PLUS approved by the FDA?
Comet-PLUS received FDA 510(k) clearance on 2017-11-03, under approval number K172711.
What company makes Comet-PLUS?
Comet-PLUS is manufactured by Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek).
What is the FDA product code for Comet-PLUS?
The FDA product code for Comet-PLUS is OLV.
Other Devices by Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)
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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.