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FDA 510(k)

PE-210AK SWITCH BOX

K-Number: K110376 · 2011-07-29

ApplicantNihon Kohden Corp.
Decision Date2011-07-29
Product CodeGWQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

PE-210AK SWITCH BOX is the device name listed in this FDA 510(k) record. The listed applicant is Nihon Kohden Corp.. It received FDA 510(k) clearance on 2011-07-29 under 510(k) number K110376. 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 PE-210AK SWITCH BOX?

PE-210AK SWITCH BOX is a medical device that received FDA 510(k) clearance on 2011-07-29. The listed applicant is Nihon Kohden Corp.. The 510(k) number is K110376.

When did PE-210AK SWITCH BOX receive FDA 510(k) clearance?

PE-210AK SWITCH BOX received FDA 510(k) clearance on 2011-07-29, under 510(k) number K110376.

Who is the listed applicant for PE-210AK SWITCH BOX?

The FDA 510(k) record lists Nihon Kohden Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PE-210AK SWITCH BOX?

The FDA product code for PE-210AK SWITCH BOX is GWQ.

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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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