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FDA 510(k)

SLEEPSCAN AIRFLOW PRESSURE TRANSDUCER

K-Number: K971501 · 1997-10-14

ApplicantBio-Logic Systems Corp.
Decision Date1997-10-14
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SLEEPSCAN AIRFLOW PRESSURE TRANSDUCER 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 1997-10-14 under 510(k) number K971501. 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 SLEEPSCAN AIRFLOW PRESSURE TRANSDUCER?

SLEEPSCAN AIRFLOW PRESSURE TRANSDUCER is a medical device that received FDA 510(k) clearance on 1997-10-14. The listed applicant is Bio-Logic Systems Corp.. The 510(k) number is K971501.

When did SLEEPSCAN AIRFLOW PRESSURE TRANSDUCER receive FDA 510(k) clearance?

SLEEPSCAN AIRFLOW PRESSURE TRANSDUCER received FDA 510(k) clearance on 1997-10-14, under 510(k) number K971501.

Who is the listed applicant for SLEEPSCAN AIRFLOW PRESSURE TRANSDUCER?

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 SLEEPSCAN AIRFLOW PRESSURE TRANSDUCER?

The FDA product code for SLEEPSCAN AIRFLOW PRESSURE TRANSDUCER is MNR.

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Other records listing Bio-Logic Systems Corp. as applicant

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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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