FDA 510(k)

SPEAC System

K-Number: K182180 · 2019-05-11

Decision Date2019-05-11

Product CodePOS

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

SPEAC System is the device name listed in this FDA 510(k) record. The listed applicant is Brain Sentinel, Inc.. It received FDA 510(k) clearance on 2019-05-11 under 510(k) 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. The listed applicant is Brain Sentinel, Inc.. The 510(k) number is K182180.

When did SPEAC System receive FDA 510(k) clearance?

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

Who is the listed applicant for SPEAC System?

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

What is the FDA product code for SPEAC System?

The FDA product code for SPEAC System is POS.

Other records listing Brain Sentinel, 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.

K200276SPEAC System

Related Devices (Code: POS)

K251506Nelli (Version 7.11)Neuro Event Labs OY K243199NightWatch+ USLivassured BV K250515EpiMonitorEmpatica S.r.l.K243515EpiWatch Monitoring SystemEpiwatch, Inc.K232915EpiMonitorEmpatica S.r.l.K200276SPEAC SystemBrain Sentinel, Inc.

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.