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FDA 510(k)

VISTA GRAPH POLYSOMNOGRAPHY AMPLIFIER

K-Number: K904222 · 1991-01-18

ApplicantTelediagnostic Systems, Inc.
Decision Date1991-01-18
Product CodeGWL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

VISTA GRAPH POLYSOMNOGRAPHY AMPLIFIER 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 1991-01-18 under 510(k) number K904222. The device is classified under product code GWL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VISTA GRAPH POLYSOMNOGRAPHY AMPLIFIER?

VISTA GRAPH POLYSOMNOGRAPHY AMPLIFIER is a medical device that received FDA 510(k) clearance on 1991-01-18. The listed applicant is Telediagnostic Systems, Inc.. The 510(k) number is K904222.

When did VISTA GRAPH POLYSOMNOGRAPHY AMPLIFIER receive FDA 510(k) clearance?

VISTA GRAPH POLYSOMNOGRAPHY AMPLIFIER received FDA 510(k) clearance on 1991-01-18, under 510(k) number K904222.

Who is the listed applicant for VISTA GRAPH POLYSOMNOGRAPHY AMPLIFIER?

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 VISTA GRAPH POLYSOMNOGRAPHY AMPLIFIER?

The FDA product code for VISTA GRAPH POLYSOMNOGRAPHY AMPLIFIER is GWL.

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Other records listing Telediagnostic Systems, Inc. as applicant

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Related Devices (Code: GWL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243746Delphi AmplifierQuantalx NeroscienceK242832NExT Station; NExT Station AdvancedEb Neuro S.P.A.K242305BE Plus PRO, Neurotravel LIGHTEb Neuro S.P.A.K240646DreamClearSomnomed Technologies Inc., Doing Business AS RemwareK232210X-trodes System MX-TrodesK230148VlabDormotech Medical, Ltd.

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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