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FDA 510(k)

NEUROLAB II

K-Number: K844481 · 1985-05-20

ApplicantTeca, Inc.
Decision Date1985-05-20
Product CodeGWS
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NEUROLAB II is the device name listed in this FDA 510(k) record. The listed applicant is Teca, Inc.. It received FDA 510(k) clearance on 1985-05-20 under 510(k) number K844481. The device is classified under product code GWS. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEUROLAB II?

NEUROLAB II is a medical device that received FDA 510(k) clearance on 1985-05-20. The listed applicant is Teca, Inc.. The 510(k) number is K844481.

When did NEUROLAB II receive FDA 510(k) clearance?

NEUROLAB II received FDA 510(k) clearance on 1985-05-20, under 510(k) number K844481.

Who is the listed applicant for NEUROLAB II?

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

What is the FDA product code for NEUROLAB II?

The FDA product code for NEUROLAB II is GWS.

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Other records listing Teca, Inc. as applicant

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Related Devices (Code: GWS)

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.

K974718PERSYST PRISMPersyst Development Corp.K925735EEG ANALYZERBio-Scan, Inc.K912938RHYTHMStellate SystemsK894629NICOLET BEAM II SYSTEMNicolet Instrument Corp.K871931ISTAT SOFTWARENeuroscience, Inc.K871480STD-228 SPECTRAL TREND DISPLAYGrass-Telefactor Product Group

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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