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FDA 510(k)

DSXL DIFFUSION SPIROMETER

K-Number: K961252 · 1997-02-14

ApplicantInair , Ltd.
Decision Date1997-02-14
Product CodeBTY
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

DSXL DIFFUSION SPIROMETER is the device name listed in this FDA 510(k) record. The listed applicant is Inair , Ltd.. It received FDA 510(k) clearance on 1997-02-14 under 510(k) number K961252. The device is classified under product code BTY. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DSXL DIFFUSION SPIROMETER?

DSXL DIFFUSION SPIROMETER is a medical device that received FDA 510(k) clearance on 1997-02-14. The listed applicant is Inair , Ltd.. The 510(k) number is K961252.

When did DSXL DIFFUSION SPIROMETER receive FDA 510(k) clearance?

DSXL DIFFUSION SPIROMETER received FDA 510(k) clearance on 1997-02-14, under 510(k) number K961252.

Who is the listed applicant for DSXL DIFFUSION SPIROMETER?

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

What is the FDA product code for DSXL DIFFUSION SPIROMETER?

The FDA product code for DSXL DIFFUSION SPIROMETER is BTY.

Related Clinical Trials

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Related Devices (Code: BTY)

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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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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