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FDA 510(k)

CNS 4/8 AND CT 48.1 SOFTWARE

K-Number: K860829 · 1986-05-29

ApplicantCns, Inc.
Decision Date1986-05-29
Product CodeGWS
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

CNS 4/8 AND CT 48.1 SOFTWARE is the device name listed in this FDA 510(k) record. The listed applicant is Cns, Inc.. It received FDA 510(k) clearance on 1986-05-29 under 510(k) number K860829. 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 CNS 4/8 AND CT 48.1 SOFTWARE?

CNS 4/8 AND CT 48.1 SOFTWARE is a medical device that received FDA 510(k) clearance on 1986-05-29. The listed applicant is Cns, Inc.. The 510(k) number is K860829.

When did CNS 4/8 AND CT 48.1 SOFTWARE receive FDA 510(k) clearance?

CNS 4/8 AND CT 48.1 SOFTWARE received FDA 510(k) clearance on 1986-05-29, under 510(k) number K860829.

Who is the listed applicant for CNS 4/8 AND CT 48.1 SOFTWARE?

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

What is the FDA product code for CNS 4/8 AND CT 48.1 SOFTWARE?

The FDA product code for CNS 4/8 AND CT 48.1 SOFTWARE is GWS.

Related Clinical Trials

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.

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Other records listing Cns, 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.

K955711BREATHE RIGHT NASAL STRIPK954914BREATHE RIGHT NASAL STRIPK953772BREATHE RIGHT NASAL STRIPK950273SLEEP TEST(TM)K921220BREATHE RIGHTK912436AM-PAK

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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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