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FDA 510(k)

SATELLITE

K-Number: K971331 · 1997-06-25

ApplicantNicolet Biomedical, Inc.
Decision Date1997-06-25
Product CodeGWQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SATELLITE is the device name listed in this FDA 510(k) record. The listed applicant is Nicolet Biomedical, Inc.. It received FDA 510(k) clearance on 1997-06-25 under 510(k) number K971331. The device is classified under product code GWQ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SATELLITE?

SATELLITE is a medical device that received FDA 510(k) clearance on 1997-06-25. The listed applicant is Nicolet Biomedical, Inc.. The 510(k) number is K971331.

When did SATELLITE receive FDA 510(k) clearance?

SATELLITE received FDA 510(k) clearance on 1997-06-25, under 510(k) number K971331.

Who is the listed applicant for SATELLITE?

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

What is the FDA product code for SATELLITE?

The FDA product code for SATELLITE is GWQ.

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Other records listing Nicolet Biomedical, Inc. as applicant

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Related Devices (Code: GWQ)

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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