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FDA 510(k)

HEALTHDYNE'S EVENT RECORDER SYSTEM

K-Number: K860254 · 1986-01-30

ApplicantHealthdyne, Inc.
Decision Date1986-01-30
Product CodeBZQ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

HEALTHDYNE'S EVENT RECORDER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Healthdyne, Inc.. It received FDA 510(k) clearance on 1986-01-30 under 510(k) number K860254. The device is classified under product code BZQ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEALTHDYNE'S EVENT RECORDER SYSTEM?

HEALTHDYNE'S EVENT RECORDER SYSTEM is a medical device that received FDA 510(k) clearance on 1986-01-30. The listed applicant is Healthdyne, Inc.. The 510(k) number is K860254.

When did HEALTHDYNE'S EVENT RECORDER SYSTEM receive FDA 510(k) clearance?

HEALTHDYNE'S EVENT RECORDER SYSTEM received FDA 510(k) clearance on 1986-01-30, under 510(k) number K860254.

Who is the listed applicant for HEALTHDYNE'S EVENT RECORDER SYSTEM?

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

What is the FDA product code for HEALTHDYNE'S EVENT RECORDER SYSTEM?

The FDA product code for HEALTHDYNE'S EVENT RECORDER SYSTEM is BZQ.

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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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