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FDA 510(k)

CA2000

K-Number: K842611 · 1984-07-20

ApplicantNicolet Biomedical Instruments
Decision Date1984-07-20
Product CodeIKN
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

CA2000 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 1984-07-20 under 510(k) number K842611. The device is classified under product code IKN. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CA2000?

CA2000 is a medical device that received FDA 510(k) clearance on 1984-07-20. The listed applicant is Nicolet Biomedical Instruments. The 510(k) number is K842611.

When did CA2000 receive FDA 510(k) clearance?

CA2000 received FDA 510(k) clearance on 1984-07-20, under 510(k) number K842611.

Who is the listed applicant for CA2000?

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 CA2000?

The FDA product code for CA2000 is IKN.

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: IKN)

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.

K172743Natus VikingQuestNatus Neurology IncorporatedK163150ViMove2Dorsavi, Ltd.K162383Cadwell Sierra Summit, Cadwell Sierra AscentCadwell Industries, Inc.K123902PHYSICAL MONITORING REGISTRATION UNIT-S (PMRU-S)Oktx, LLCK123399MYOVISION 3.0 WIREFREE SYSTEMPrecision Biometrics, Inc.K113074CMAP PROMedical Technologies, 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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