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FDA 510(k)

Natus Ultrapro S100 (982A0594)

K-Number: K243495 · 2024-12-12

ApplicantNatus Neurology Incorporated
Decision Date2024-12-12
Product CodeGWF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Natus Ultrapro S100 (982A0594) is the device name listed in this FDA 510(k) record. The listed applicant is Natus Neurology Incorporated. It received FDA 510(k) clearance on 2024-12-12 under 510(k) number K243495. The device is classified under product code GWF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Natus Ultrapro S100 (982A0594)?

Natus Ultrapro S100 (982A0594) is a medical device that received FDA 510(k) clearance on 2024-12-12. The listed applicant is Natus Neurology Incorporated. The 510(k) number is K243495.

When did Natus Ultrapro S100 (982A0594) receive FDA 510(k) clearance?

Natus Ultrapro S100 (982A0594) received FDA 510(k) clearance on 2024-12-12, under 510(k) number K243495.

Who is the listed applicant for Natus Ultrapro S100 (982A0594)?

The FDA 510(k) record lists Natus Neurology Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Natus Ultrapro S100 (982A0594)?

The FDA product code for Natus Ultrapro S100 (982A0594) is GWF.

Other records listing Natus Neurology Incorporated 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.

K243982Nicolet EDXK173366NicoletOneK172743Natus VikingQuest

Related Devices (Code: GWF)

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.

K253301BraiN20® (BraiN20)Time IS Brain, S.L.K252842SafeOp 3: Neural Informatix SystemAlphatec Spine, Inc.K243982Nicolet EDXNatus Neurology IncorporatedK242345Delphi StimulatorQuantalx NeuroscienceK234092SafeOp 3: Neural Informatix SysteemAlphatec Spine, Inc.K234080MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S)Soterix Medical, 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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