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FDA 510(k)

VITALOGRAPH MODEL 4000 (ASMA-1 AND COPD-6)

K-Number: K073155 · 2008-06-04

ApplicantVitalograph (Ireland) , Ltd.
Decision Date2008-06-04
Product CodeBZG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

VITALOGRAPH MODEL 4000 (ASMA-1 AND COPD-6) is the device name listed in this FDA 510(k) record. The listed applicant is Vitalograph (Ireland) , Ltd.. It received FDA 510(k) clearance on 2008-06-04 under 510(k) number K073155. 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 VITALOGRAPH MODEL 4000 (ASMA-1 AND COPD-6)?

VITALOGRAPH MODEL 4000 (ASMA-1 AND COPD-6) is a medical device that received FDA 510(k) clearance on 2008-06-04. The listed applicant is Vitalograph (Ireland) , Ltd.. The 510(k) number is K073155.

When did VITALOGRAPH MODEL 4000 (ASMA-1 AND COPD-6) receive FDA 510(k) clearance?

VITALOGRAPH MODEL 4000 (ASMA-1 AND COPD-6) received FDA 510(k) clearance on 2008-06-04, under 510(k) number K073155.

Who is the listed applicant for VITALOGRAPH MODEL 4000 (ASMA-1 AND COPD-6)?

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

What is the FDA product code for VITALOGRAPH MODEL 4000 (ASMA-1 AND COPD-6)?

The FDA product code for VITALOGRAPH MODEL 4000 (ASMA-1 AND COPD-6) is BZG.

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Other records listing Vitalograph (Ireland) , Ltd. 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.

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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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