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FDA 510(k)

COMPUTER-AIDED ELECTROCARDIOGRAPH FCP200

K-Number: K823586 · 1983-04-06

ApplicantBrentwood Instruments, Inc.
Decision Date1983-04-06
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

COMPUTER-AIDED ELECTROCARDIOGRAPH FCP200 is the device name listed in this FDA 510(k) record. The listed applicant is Brentwood Instruments, Inc.. It received FDA 510(k) clearance on 1983-04-06 under 510(k) number K823586. The device is classified under product code DSI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMPUTER-AIDED ELECTROCARDIOGRAPH FCP200?

COMPUTER-AIDED ELECTROCARDIOGRAPH FCP200 is a medical device that received FDA 510(k) clearance on 1983-04-06. The listed applicant is Brentwood Instruments, Inc.. The 510(k) number is K823586.

When did COMPUTER-AIDED ELECTROCARDIOGRAPH FCP200 receive FDA 510(k) clearance?

COMPUTER-AIDED ELECTROCARDIOGRAPH FCP200 received FDA 510(k) clearance on 1983-04-06, under 510(k) number K823586.

Who is the listed applicant for COMPUTER-AIDED ELECTROCARDIOGRAPH FCP200?

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

What is the FDA product code for COMPUTER-AIDED ELECTROCARDIOGRAPH FCP200?

The FDA product code for COMPUTER-AIDED ELECTROCARDIOGRAPH FCP200 is DSI.

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Other records listing Brentwood Instruments, Inc. as applicant

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Related Devices (Code: DSI)

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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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