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FDA 510(k)

ADDITION OF BUILT-IN OXYMETER TO SLEEPSCAN PROD.

K-Number: K930790 · 1994-01-06

Decision Date1994-01-06
Product CodeBZQ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ADDITION OF BUILT-IN OXYMETER TO SLEEPSCAN PROD. 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 1994-01-06 under 510(k) number K930790. The device is classified under product code BZQ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADDITION OF BUILT-IN OXYMETER TO SLEEPSCAN PROD.?

ADDITION OF BUILT-IN OXYMETER TO SLEEPSCAN PROD. is a medical device that received FDA 510(k) clearance on 1994-01-06. The listed applicant is Bio-Logic Systems Corp.. The 510(k) number is K930790.

When did ADDITION OF BUILT-IN OXYMETER TO SLEEPSCAN PROD. receive FDA 510(k) clearance?

ADDITION OF BUILT-IN OXYMETER TO SLEEPSCAN PROD. received FDA 510(k) clearance on 1994-01-06, under 510(k) number K930790.

Who is the listed applicant for ADDITION OF BUILT-IN OXYMETER TO SLEEPSCAN PROD.?

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 ADDITION OF BUILT-IN OXYMETER TO SLEEPSCAN PROD.?

The FDA product code for ADDITION OF BUILT-IN OXYMETER TO SLEEPSCAN PROD. is BZQ.

Related Clinical Trials

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.

Other records listing Bio-Logic Systems Corp. 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: BZQ)

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.

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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