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FDA 510(k)

AMBULATORY EEG/SLEEP RECORDER AND ACCESSORIES, MODEL # SSR3201

K-Number: K983072 · 1998-12-01

ApplicantNihon Kohden America, Inc.
Decision Date1998-12-01
Product CodeOLV
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

AMBULATORY EEG/SLEEP RECORDER AND ACCESSORIES, MODEL # SSR3201 is the device name listed in this FDA 510(k) record. The listed applicant is Nihon Kohden America, Inc.. It received FDA 510(k) clearance on 1998-12-01 under 510(k) number K983072. The device is classified under product code OLV. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMBULATORY EEG/SLEEP RECORDER AND ACCESSORIES, MODEL # SSR3201?

AMBULATORY EEG/SLEEP RECORDER AND ACCESSORIES, MODEL # SSR3201 is a medical device that received FDA 510(k) clearance on 1998-12-01. The listed applicant is Nihon Kohden America, Inc.. The 510(k) number is K983072.

When did AMBULATORY EEG/SLEEP RECORDER AND ACCESSORIES, MODEL # SSR3201 receive FDA 510(k) clearance?

AMBULATORY EEG/SLEEP RECORDER AND ACCESSORIES, MODEL # SSR3201 received FDA 510(k) clearance on 1998-12-01, under 510(k) number K983072.

Who is the listed applicant for AMBULATORY EEG/SLEEP RECORDER AND ACCESSORIES, MODEL # SSR3201?

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

What is the FDA product code for AMBULATORY EEG/SLEEP RECORDER AND ACCESSORIES, MODEL # SSR3201?

The FDA product code for AMBULATORY EEG/SLEEP RECORDER AND ACCESSORIES, MODEL # SSR3201 is OLV.

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Other records listing Nihon Kohden America, Inc. 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.

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Related Devices (Code: OLV)

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.

K261747Report StudioBeacon Biosignals, Inc.K260585Noxturnal WebNox Medical EhfK242447Falcon HSTCompumedics LimitedK241288Noxturnal WebNox Medical EhfK240700HomeSleepTest (HST, HST REM+)Somnomedics GmbHK213007Cerebra Sleep SystemCerebra Medical , Ltd.

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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