FDA 510(k)

ASTRASONIC SPIROMETER, MODEL 29-8000

K-Number: K092813 · 2010-07-16

Decision Date2010-07-16

Product CodeBZG

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

ASTRASONIC SPIROMETER, MODEL 29-8000 is the device name listed in this FDA 510(k) record. The listed applicant is Sdi Diagnostics, Inc.. It received FDA 510(k) clearance on 2010-07-16 under 510(k) number K092813. The device is classified under product code BZG. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ASTRASONIC SPIROMETER, MODEL 29-8000?

ASTRASONIC SPIROMETER, MODEL 29-8000 is a medical device that received FDA 510(k) clearance on 2010-07-16. The listed applicant is Sdi Diagnostics, Inc.. The 510(k) number is K092813.

When did ASTRASONIC SPIROMETER, MODEL 29-8000 receive FDA 510(k) clearance?

ASTRASONIC SPIROMETER, MODEL 29-8000 received FDA 510(k) clearance on 2010-07-16, under 510(k) number K092813.

Who is the listed applicant for ASTRASONIC SPIROMETER, MODEL 29-8000?

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

What is the FDA product code for ASTRASONIC SPIROMETER, MODEL 29-8000?

The FDA product code for ASTRASONIC SPIROMETER, MODEL 29-8000 is BZG.

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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.