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FDA 510(k)

DUAL CHENNEL BRAIN ACTIVITY MONITOR

K-Number: K843808 · 1984-11-08

ApplicantDatex Division Instrumentarium Corp.
Decision Date1984-11-08
Product CodeOLT
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

DUAL CHENNEL BRAIN ACTIVITY MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Datex Division Instrumentarium Corp.. It received FDA 510(k) clearance on 1984-11-08 under 510(k) number K843808. The device is classified under product code OLT. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DUAL CHENNEL BRAIN ACTIVITY MONITOR?

DUAL CHENNEL BRAIN ACTIVITY MONITOR is a medical device that received FDA 510(k) clearance on 1984-11-08. The listed applicant is Datex Division Instrumentarium Corp.. The 510(k) number is K843808.

When did DUAL CHENNEL BRAIN ACTIVITY MONITOR receive FDA 510(k) clearance?

DUAL CHENNEL BRAIN ACTIVITY MONITOR received FDA 510(k) clearance on 1984-11-08, under 510(k) number K843808.

Who is the listed applicant for DUAL CHENNEL BRAIN ACTIVITY MONITOR?

The FDA 510(k) record lists Datex Division Instrumentarium Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DUAL CHENNEL BRAIN ACTIVITY MONITOR?

The FDA product code for DUAL CHENNEL BRAIN ACTIVITY MONITOR is OLT.

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Other records listing Datex Division Instrumentarium Corp. as applicant

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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.

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