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FDA 510(k)

SIMON MULTICHANNEL RECORDING SYSTEM, MODEL 5500

K-Number: K983572 · 1999-03-19

ApplicantHealthdyne Technologies, Inc.
Decision Date1999-03-19
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SIMON MULTICHANNEL RECORDING SYSTEM, MODEL 5500 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 1999-03-19 under 510(k) number K983572. The device is classified under product code MNR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIMON MULTICHANNEL RECORDING SYSTEM, MODEL 5500?

SIMON MULTICHANNEL RECORDING SYSTEM, MODEL 5500 is a medical device that received FDA 510(k) clearance on 1999-03-19. The listed applicant is Healthdyne Technologies, Inc.. The 510(k) number is K983572.

When did SIMON MULTICHANNEL RECORDING SYSTEM, MODEL 5500 receive FDA 510(k) clearance?

SIMON MULTICHANNEL RECORDING SYSTEM, MODEL 5500 received FDA 510(k) clearance on 1999-03-19, under 510(k) number K983572.

Who is the listed applicant for SIMON MULTICHANNEL RECORDING SYSTEM, MODEL 5500?

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 SIMON MULTICHANNEL RECORDING SYSTEM, MODEL 5500?

The FDA product code for SIMON MULTICHANNEL RECORDING SYSTEM, MODEL 5500 is MNR.

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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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