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FDA 510(k)

BIO-LOGIC SLEEPSCAN PRODUCT WITH BUILT-IN OXIMETER

K-Number: K962103 · 1996-08-22

ApplicantBio-Logic Systems Corp.
Decision Date1996-08-22
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BIO-LOGIC SLEEPSCAN PRODUCT WITH BUILT-IN OXIMETER is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Logic Systems Corp.. It received FDA 510(k) clearance on 1996-08-22 under 510(k) number K962103. The device is classified under product code MNR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIO-LOGIC SLEEPSCAN PRODUCT WITH BUILT-IN OXIMETER?

BIO-LOGIC SLEEPSCAN PRODUCT WITH BUILT-IN OXIMETER is a medical device that received FDA 510(k) clearance on 1996-08-22. The listed applicant is Bio-Logic Systems Corp.. The 510(k) number is K962103.

When did BIO-LOGIC SLEEPSCAN PRODUCT WITH BUILT-IN OXIMETER receive FDA 510(k) clearance?

BIO-LOGIC SLEEPSCAN PRODUCT WITH BUILT-IN OXIMETER received FDA 510(k) clearance on 1996-08-22, under 510(k) number K962103.

Who is the listed applicant for BIO-LOGIC SLEEPSCAN PRODUCT WITH BUILT-IN OXIMETER?

The FDA 510(k) record lists Bio-Logic Systems Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIO-LOGIC SLEEPSCAN PRODUCT WITH BUILT-IN OXIMETER?

The FDA product code for BIO-LOGIC SLEEPSCAN PRODUCT WITH BUILT-IN OXIMETER is MNR.

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Other records listing Bio-Logic Systems Corp. as applicant

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Related Devices (Code: MNR)

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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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