FDA 510(k)

MIR SPIROBANK SPIROMETER

K-Number: K983909 · 1998-12-21

Decision Date1998-12-21

Product CodeBZG

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

MIR SPIROBANK SPIROMETER is the device name listed in this FDA 510(k) record. The listed applicant is Mir Medical Intl. Research Srl. It received FDA 510(k) clearance on 1998-12-21 under 510(k) number K983909. 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 MIR SPIROBANK SPIROMETER?

MIR SPIROBANK SPIROMETER is a medical device that received FDA 510(k) clearance on 1998-12-21. The listed applicant is Mir Medical Intl. Research Srl. The 510(k) number is K983909.

When did MIR SPIROBANK SPIROMETER receive FDA 510(k) clearance?

MIR SPIROBANK SPIROMETER received FDA 510(k) clearance on 1998-12-21, under 510(k) number K983909.

Who is the listed applicant for MIR SPIROBANK SPIROMETER?

The FDA 510(k) record lists Mir Medical Intl. Research Srl as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MIR SPIROBANK SPIROMETER?

The FDA product code for MIR SPIROBANK SPIROMETER is BZG.

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Other records listing Mir Medical Intl. Research Srl 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.