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FDA 510(k)

COMPUTER-AIDED ELECTROCARDIOGRAPH FCP-13

K-Number: K823585 · 1983-04-06

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

Device Summary

COMPUTER-AIDED ELECTROCARDIOGRAPH FCP-13 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 K823585. 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 FCP-13?

COMPUTER-AIDED ELECTROCARDIOGRAPH FCP-13 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 K823585.

When did COMPUTER-AIDED ELECTROCARDIOGRAPH FCP-13 receive FDA 510(k) clearance?

COMPUTER-AIDED ELECTROCARDIOGRAPH FCP-13 received FDA 510(k) clearance on 1983-04-06, under 510(k) number K823585.

Who is the listed applicant for COMPUTER-AIDED ELECTROCARDIOGRAPH FCP-13?

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 FCP-13?

The FDA product code for COMPUTER-AIDED ELECTROCARDIOGRAPH FCP-13 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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