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FDA 510(k)

CNS-16 & LTM 1.0 SOFTWARE

K-Number: K854160 · 1986-01-10

ApplicantCns, Inc.
Decision Date1986-01-10
Product CodeGWS
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

CNS-16 & LTM 1.0 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 1986-01-10 under 510(k) number K854160. 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-16 & LTM 1.0 SOFTWARE?

CNS-16 & LTM 1.0 SOFTWARE is a medical device that received FDA 510(k) clearance on 1986-01-10. The listed applicant is Cns, Inc.. The 510(k) number is K854160.

When did CNS-16 & LTM 1.0 SOFTWARE receive FDA 510(k) clearance?

CNS-16 & LTM 1.0 SOFTWARE received FDA 510(k) clearance on 1986-01-10, under 510(k) number K854160.

Who is the listed applicant for CNS-16 & LTM 1.0 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-16 & LTM 1.0 SOFTWARE?

The FDA product code for CNS-16 & LTM 1.0 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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