FDA 510(k)

SPIROTEL, MODEL 29-1020

K-Number: K031643 · 2003-12-09

Decision Date2003-12-09

Product CodeBZG

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

SPIROTEL, MODEL 29-1020 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 2003-12-09 under 510(k) number K031643. 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 SPIROTEL, MODEL 29-1020?

SPIROTEL, MODEL 29-1020 is a medical device that received FDA 510(k) clearance on 2003-12-09. The listed applicant is Sdi Diagnostics, Inc.. The 510(k) number is K031643.

When did SPIROTEL, MODEL 29-1020 receive FDA 510(k) clearance?

SPIROTEL, MODEL 29-1020 received FDA 510(k) clearance on 2003-12-09, under 510(k) number K031643.

Who is the listed applicant for SPIROTEL, MODEL 29-1020?

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 SPIROTEL, MODEL 29-1020?

The FDA product code for SPIROTEL, MODEL 29-1020 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.