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FDA 510(k)

MODEL 7410 VOYAGER

K-Number: K974879 · 1998-06-29

ApplicantHealthdyne Technologies, Inc.
Decision Date1998-06-29
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MODEL 7410 VOYAGER is the device name listed in this FDA 510(k) record. The listed applicant is Healthdyne Technologies, Inc.. It received FDA 510(k) clearance on 1998-06-29 under 510(k) number K974879. The device is classified under product code BZD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL 7410 VOYAGER?

MODEL 7410 VOYAGER is a medical device that received FDA 510(k) clearance on 1998-06-29. The listed applicant is Healthdyne Technologies, Inc.. The 510(k) number is K974879.

When did MODEL 7410 VOYAGER receive FDA 510(k) clearance?

MODEL 7410 VOYAGER received FDA 510(k) clearance on 1998-06-29, under 510(k) number K974879.

Who is the listed applicant for MODEL 7410 VOYAGER?

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

What is the FDA product code for MODEL 7410 VOYAGER?

The FDA product code for MODEL 7410 VOYAGER is BZD.

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Other records listing Healthdyne Technologies, Inc. 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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