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FDA 510(k)

SLEEP STUDY ANALYSIS (SSA) VERSION 96.10

K-Number: K963631 · 1997-04-02

ApplicantOmega Results
Decision Date1997-04-02
Product CodeOLZ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SLEEP STUDY ANALYSIS (SSA) VERSION 96.10 is the device name listed in this FDA 510(k) record. The listed applicant is Omega Results. It received FDA 510(k) clearance on 1997-04-02 under 510(k) number K963631. The device is classified under product code OLZ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SLEEP STUDY ANALYSIS (SSA) VERSION 96.10?

SLEEP STUDY ANALYSIS (SSA) VERSION 96.10 is a medical device that received FDA 510(k) clearance on 1997-04-02. The listed applicant is Omega Results. The 510(k) number is K963631.

When did SLEEP STUDY ANALYSIS (SSA) VERSION 96.10 receive FDA 510(k) clearance?

SLEEP STUDY ANALYSIS (SSA) VERSION 96.10 received FDA 510(k) clearance on 1997-04-02, under 510(k) number K963631.

Who is the listed applicant for SLEEP STUDY ANALYSIS (SSA) VERSION 96.10?

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

What is the FDA product code for SLEEP STUDY ANALYSIS (SSA) VERSION 96.10?

The FDA product code for SLEEP STUDY ANALYSIS (SSA) VERSION 96.10 is OLZ.

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Related Devices (Code: OLZ)

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.

K253390SOMNUM (SOMNUM)Honeynaps Co., Ltd.K253668Onera SleepMap (SLEEPMAP)Onera B.V.K250851Hypnos (369054-200)Cadwell Industries, Inc.K252330DeepRESPNox Medical EhfK250058NEAT 001Brain Electrophysiology Laboratory Company, LLCK241960DeepRESPNox Medical Ehf

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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