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FDA 510(k)

NICOLET EMG SATELLITE

K-Number: K830702 · 1983-07-12

ApplicantNicolet Biomedical Instruments
Decision Date1983-07-12
Product CodeIKN
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

NICOLET EMG SATELLITE 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 1983-07-12 under 510(k) number K830702. 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 NICOLET EMG SATELLITE?

NICOLET EMG SATELLITE is a medical device that received FDA 510(k) clearance on 1983-07-12. The listed applicant is Nicolet Biomedical Instruments. The 510(k) number is K830702.

When did NICOLET EMG SATELLITE receive FDA 510(k) clearance?

NICOLET EMG SATELLITE received FDA 510(k) clearance on 1983-07-12, under 510(k) number K830702.

Who is the listed applicant for NICOLET EMG SATELLITE?

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 NICOLET EMG SATELLITE?

The FDA product code for NICOLET EMG SATELLITE is IKN.

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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.

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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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