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FDA 510(k)

NIGHTRON POLYSOMNOGRAPHY SYSTEM

K-Number: K022249 · 2002-12-31

ApplicantTelediagnostic Systems, Inc.
Decision Date2002-12-31
Product CodeOLV
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NIGHTRON POLYSOMNOGRAPHY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Telediagnostic Systems, Inc.. It received FDA 510(k) clearance on 2002-12-31 under 510(k) number K022249. The device is classified under product code OLV. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NIGHTRON POLYSOMNOGRAPHY SYSTEM?

NIGHTRON POLYSOMNOGRAPHY SYSTEM is a medical device that received FDA 510(k) clearance on 2002-12-31. The listed applicant is Telediagnostic Systems, Inc.. The 510(k) number is K022249.

When did NIGHTRON POLYSOMNOGRAPHY SYSTEM receive FDA 510(k) clearance?

NIGHTRON POLYSOMNOGRAPHY SYSTEM received FDA 510(k) clearance on 2002-12-31, under 510(k) number K022249.

Who is the listed applicant for NIGHTRON POLYSOMNOGRAPHY SYSTEM?

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

What is the FDA product code for NIGHTRON POLYSOMNOGRAPHY SYSTEM?

The FDA product code for NIGHTRON POLYSOMNOGRAPHY SYSTEM is OLV.

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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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