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FDA 510(k)

VISTA POLYSOMNOGRAPHY COMPUTER SYSTEM

K-Number: K904328 · 1991-06-18

ApplicantTelediagnostic Systems, Inc.
Decision Date1991-06-18
Product CodeGWK
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

VISTA POLYSOMNOGRAPHY COMPUTER 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 1991-06-18 under 510(k) number K904328. The device is classified under product code GWK. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VISTA POLYSOMNOGRAPHY COMPUTER SYSTEM?

VISTA POLYSOMNOGRAPHY COMPUTER SYSTEM is a medical device that received FDA 510(k) clearance on 1991-06-18. The listed applicant is Telediagnostic Systems, Inc.. The 510(k) number is K904328.

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

VISTA POLYSOMNOGRAPHY COMPUTER SYSTEM received FDA 510(k) clearance on 1991-06-18, under 510(k) number K904328.

Who is the listed applicant for VISTA POLYSOMNOGRAPHY COMPUTER 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 VISTA POLYSOMNOGRAPHY COMPUTER SYSTEM?

The FDA product code for VISTA POLYSOMNOGRAPHY COMPUTER SYSTEM is GWK.

Related Clinical Trials

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Other records listing Telediagnostic Systems, Inc. as applicant

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.

K071661ALPHAONE BIOFEEDBACK SYSTEMK022249NIGHTRON POLYSOMNOGRAPHY SYSTEMK970659DT-24 TELEPHONIC EEG TRANSMITTER/DR-24 TELEPHONIC EEG RECEIVERK904222VISTA GRAPH POLYSOMNOGRAPHY AMPLIFIERK885328RS-10 TELEPHONIC POLYSOMNOGRAPHY RECEIVERK884891OC-100 OXIMETER INTERFACE CALIBRATOR

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Related Devices (Code: GWK)

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.

K060919ACTICALRespironics, Inc.K061870VITALSENSE XHRRespironics, Inc.K052489ACTIHEARTRespironics, Inc.K991045MINI-LOGGER SERIES 2000Mini-Mitter Co., Inc.K905594NEUROFILE DATA STORAGE/ACCESORIES TO THE EEG-4300Nihon Kohden America, Inc.K896164ASC-954 INTEGRATOR AMPLIFIERAstro-Med, Inc.

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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