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FDA 510(k)

PROTEKTOR 32

K-Number: K093304 · 2010-08-11

ApplicantNatus Medical, Inc.
Decision Date2010-08-11
Product CodeGWF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

PROTEKTOR 32 is the device name listed in this FDA 510(k) record. The listed applicant is Natus Medical, Inc.. It received FDA 510(k) clearance on 2010-08-11 under 510(k) number K093304. 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 PROTEKTOR 32?

PROTEKTOR 32 is a medical device that received FDA 510(k) clearance on 2010-08-11. The listed applicant is Natus Medical, Inc.. The 510(k) number is K093304.

When did PROTEKTOR 32 receive FDA 510(k) clearance?

PROTEKTOR 32 received FDA 510(k) clearance on 2010-08-11, under 510(k) number K093304.

Who is the listed applicant for PROTEKTOR 32?

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

What is the FDA product code for PROTEKTOR 32?

The FDA product code for PROTEKTOR 32 is GWF.

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Other records listing Natus Medical, Inc. as applicant

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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.

K263010ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpressinomed Medizintechnik GmbHK253301BraiN20® (BraiN20)Time IS Brain, S.L.K252842SafeOp 3: Neural Informatix SystemAlphatec Spine, Inc.K243982Nicolet EDXNatus Neurology IncorporatedK243495Natus Ultrapro S100 (982A0594)Natus Neurology IncorporatedK242345Delphi StimulatorQuantalx Neuroscience

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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