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FDA 510(k)

MINI-CEARS COMPUTER (MODEL 1)

K-Number: K800001 · 1980-01-31

ApplicantBik Foundation, Inc.
Decision Date1980-01-31
Product CodeGWS
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MINI-CEARS COMPUTER (MODEL 1) is the device name listed in this FDA 510(k) record. The listed applicant is Bik Foundation, Inc.. It received FDA 510(k) clearance on 1980-01-31 under 510(k) number K800001. 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 MINI-CEARS COMPUTER (MODEL 1)?

MINI-CEARS COMPUTER (MODEL 1) is a medical device that received FDA 510(k) clearance on 1980-01-31. The listed applicant is Bik Foundation, Inc.. The 510(k) number is K800001.

When did MINI-CEARS COMPUTER (MODEL 1) receive FDA 510(k) clearance?

MINI-CEARS COMPUTER (MODEL 1) received FDA 510(k) clearance on 1980-01-31, under 510(k) number K800001.

Who is the listed applicant for MINI-CEARS COMPUTER (MODEL 1)?

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

What is the FDA product code for MINI-CEARS COMPUTER (MODEL 1)?

The FDA product code for MINI-CEARS COMPUTER (MODEL 1) is GWS.

Related Clinical Trials

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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