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FDA 510(k)

SPEAC System

K-Number: K182180 · 2019-05-11

ApplicantBrain Sentinel, Inc.
Decision Date2019-05-11
Product CodePOS
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SPEAC System is a medical device manufactured by Brain Sentinel, Inc.. It received FDA 510(k) clearance on 2019-05-11 under approval number K182180. The device is classified under product code POS. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPEAC System?

SPEAC System is a medical device that received FDA 510(k) clearance on 2019-05-11. It is manufactured by Brain Sentinel, Inc.. The 510(k) number is K182180.

When was SPEAC System approved by the FDA?

SPEAC System received FDA 510(k) clearance on 2019-05-11, under approval number K182180.

What company makes SPEAC System?

SPEAC System is manufactured by Brain Sentinel, Inc..

What is the FDA product code for SPEAC System?

The FDA product code for SPEAC System is POS.

Other Devices by Brain Sentinel, Inc.

K200276SPEAC System

Related Devices (Code: POS)

DEN140033CompanionLgch, Inc. K181861EmbraceEmpatica S.r.l. K172935EmbraceEmpatica S.r.l. K200276SPEAC SystemBrain Sentinel, Inc. K232915EpiMonitorEmpatica S.r.l. K251506Nelli (Version 7.11)Neuro Event Labs OY

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.

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