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FDA 510(k)

VTS-1000 VISUAL TESTING SYSTEM

K-Number: K812331 · 1981-11-16

ApplicantNicolet Biomedical Instruments
Decision Date1981-11-16
Product CodeHLX
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

VTS-1000 VISUAL TESTING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Nicolet Biomedical Instruments. It received FDA 510(k) clearance on 1981-11-16 under 510(k) number K812331. The device is classified under product code HLX. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VTS-1000 VISUAL TESTING SYSTEM?

VTS-1000 VISUAL TESTING SYSTEM is a medical device that received FDA 510(k) clearance on 1981-11-16. The listed applicant is Nicolet Biomedical Instruments. The 510(k) number is K812331.

When did VTS-1000 VISUAL TESTING SYSTEM receive FDA 510(k) clearance?

VTS-1000 VISUAL TESTING SYSTEM received FDA 510(k) clearance on 1981-11-16, under 510(k) number K812331.

Who is the listed applicant for VTS-1000 VISUAL TESTING SYSTEM?

The FDA 510(k) record lists Nicolet Biomedical Instruments as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VTS-1000 VISUAL TESTING SYSTEM?

The FDA product code for VTS-1000 VISUAL TESTING SYSTEM is HLX.

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Other records listing Nicolet Biomedical Instruments 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.

K880573MODIFIED NICOLET VIKING SYSTEMK873736NICOLET DIGITAL TWO PIECE HEARING AIDK873964NICOLET DISPOSABLE PRASS PROBEK873535NICOLET EXPERT SLEEP/WAKE ANALYSIS SYSTEMK871678NICOLET AMP 6R11 SYSTEMK862592PHOENIX SYSTEM SEVEN.

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Related Devices (Code: HLX)

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.

K003442MODIFICATION TO EDI VERIS SYSTEMElectro-Diagnostic Imaging, Inc.K983983EDI VERIS SYSTEMElectro-Diagnostic Imaging, Inc.K925741CLARUS ENDOSCOPIC HOOK KNIFEClarus Medical Systems, Inc.K914393RETINA TESTERRetina TesterK914163SCOPTOPIC SENSITIVITY TEST-1[SST-1]Lkc Technologies, Inc.K873990IRAS EDS INTERFEROMETRIC STIMULATORRandwal Instrument Co., 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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