Natus BrainWatch System
K-Number: K242930 · 2024-11-19
Decision Date2024-11-19
Product CodeOMC
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Natus BrainWatch System is a medical device manufactured by Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek). It received FDA 510(k) clearance on 2024-11-19 under approval number K242930. The device is classified under product code OMC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Natus BrainWatch System?
Natus BrainWatch System is a medical device that received FDA 510(k) clearance on 2024-11-19. It is manufactured by Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek). The 510(k) number is K242930.
When was Natus BrainWatch System approved by the FDA?
Natus BrainWatch System received FDA 510(k) clearance on 2024-11-19, under approval number K242930.
What company makes Natus BrainWatch System?
Natus BrainWatch System is manufactured by Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek).
What is the FDA product code for Natus BrainWatch System?
The FDA product code for Natus BrainWatch System is OMC.
Other Devices by Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)
Related Devices (Code: OMC)
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.