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FDA 510(k)

PSG-1100 SLEEP DIAGNOSTIC SYSTEM

K-Number: K120888 · 2012-11-09

ApplicantNihon Kohden Corp.
Decision Date2012-11-09
Product CodeGWQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

PSG-1100 SLEEP DIAGNOSTIC SYSTEM 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 2012-11-09 under 510(k) number K120888. 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 PSG-1100 SLEEP DIAGNOSTIC SYSTEM?

PSG-1100 SLEEP DIAGNOSTIC SYSTEM is a medical device that received FDA 510(k) clearance on 2012-11-09. The listed applicant is Nihon Kohden Corp.. The 510(k) number is K120888.

When did PSG-1100 SLEEP DIAGNOSTIC SYSTEM receive FDA 510(k) clearance?

PSG-1100 SLEEP DIAGNOSTIC SYSTEM received FDA 510(k) clearance on 2012-11-09, under 510(k) number K120888.

Who is the listed applicant for PSG-1100 SLEEP DIAGNOSTIC SYSTEM?

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 PSG-1100 SLEEP DIAGNOSTIC SYSTEM?

The FDA product code for PSG-1100 SLEEP DIAGNOSTIC SYSTEM is GWQ.

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Other records listing Nihon Kohden Corp. as applicant

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Related Devices (Code: 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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