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FDA 510(k)

SPIROLAB, SPIROLAB II

K-Number: K052140 · 2006-03-16

ApplicantMir Medical Intl. Research Srl
Decision Date2006-03-16
Product CodeBZG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SPIROLAB, SPIROLAB II 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 2006-03-16 under 510(k) number K052140. 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 SPIROLAB, SPIROLAB II?

SPIROLAB, SPIROLAB II is a medical device that received FDA 510(k) clearance on 2006-03-16. The listed applicant is Mir Medical Intl. Research Srl. The 510(k) number is K052140.

When did SPIROLAB, SPIROLAB II receive FDA 510(k) clearance?

SPIROLAB, SPIROLAB II received FDA 510(k) clearance on 2006-03-16, under 510(k) number K052140.

Who is the listed applicant for SPIROLAB, SPIROLAB II?

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 SPIROLAB, SPIROLAB II?

The FDA product code for SPIROLAB, SPIROLAB II is BZG.

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Other records listing Mir Medical Intl. Research Srl as applicant

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.

K130784SPIROTELK122384MINISPIRK081033MIROXIK082766MODIFICATION TO MINISPIR, SPIROLAB IIIK072979SPIROBANK GK061875MINISPIR; SPIROLAB III

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Related Devices (Code: BZG)

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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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