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FDA 510(k)

SALTER LABS ORAL/NASAL THERMAL AIRFLOW SENSOR

K-Number: K080922 · 2008-07-25

ApplicantSalter Labs, Division of Regulatory Affairs
Decision Date2008-07-25
Product CodeBZQ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SALTER LABS ORAL/NASAL THERMAL AIRFLOW SENSOR is the device name listed in this FDA 510(k) record. The listed applicant is Salter Labs, Division of Regulatory Affairs. It received FDA 510(k) clearance on 2008-07-25 under 510(k) number K080922. 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 SALTER LABS ORAL/NASAL THERMAL AIRFLOW SENSOR?

SALTER LABS ORAL/NASAL THERMAL AIRFLOW SENSOR is a medical device that received FDA 510(k) clearance on 2008-07-25. The listed applicant is Salter Labs, Division of Regulatory Affairs. The 510(k) number is K080922.

When did SALTER LABS ORAL/NASAL THERMAL AIRFLOW SENSOR receive FDA 510(k) clearance?

SALTER LABS ORAL/NASAL THERMAL AIRFLOW SENSOR received FDA 510(k) clearance on 2008-07-25, under 510(k) number K080922.

Who is the listed applicant for SALTER LABS ORAL/NASAL THERMAL AIRFLOW SENSOR?

The FDA 510(k) record lists Salter Labs, Division of Regulatory Affairs as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SALTER LABS ORAL/NASAL THERMAL AIRFLOW SENSOR?

The FDA product code for SALTER LABS ORAL/NASAL THERMAL AIRFLOW SENSOR is BZQ.

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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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