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FDA 510(k)

HyperBand

K-Number: K162403 · 2016-11-18

ApplicantGe Medical Systems, LLC
Decision Date2016-11-18
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

HyperBand is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems, LLC. It received FDA 510(k) clearance on 2016-11-18 under 510(k) number K162403. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HyperBand?

HyperBand is a medical device that received FDA 510(k) clearance on 2016-11-18. The listed applicant is Ge Medical Systems, LLC. The 510(k) number is K162403.

When did HyperBand receive FDA 510(k) clearance?

HyperBand received FDA 510(k) clearance on 2016-11-18, under 510(k) number K162403.

Who is the listed applicant for HyperBand?

The FDA 510(k) record lists Ge Medical Systems, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HyperBand?

The FDA product code for HyperBand is LNH.

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Related Devices (Code: LNH)

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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