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FDA 510(k)

ANZAI AZ-733 RESPIRATORY GATING SYSTEM

K-Number: K031385 · 2003-11-10

ApplicantAnzai Medical Co., Ltd.
Decision Date2003-11-10
Product CodeLHN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ANZAI AZ-733 RESPIRATORY GATING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Anzai Medical Co., Ltd.. It received FDA 510(k) clearance on 2003-11-10 under 510(k) number K031385. The device is classified under product code LHN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANZAI AZ-733 RESPIRATORY GATING SYSTEM?

ANZAI AZ-733 RESPIRATORY GATING SYSTEM is a medical device that received FDA 510(k) clearance on 2003-11-10. The listed applicant is Anzai Medical Co., Ltd.. The 510(k) number is K031385.

When did ANZAI AZ-733 RESPIRATORY GATING SYSTEM receive FDA 510(k) clearance?

ANZAI AZ-733 RESPIRATORY GATING SYSTEM received FDA 510(k) clearance on 2003-11-10, under 510(k) number K031385.

Who is the listed applicant for ANZAI AZ-733 RESPIRATORY GATING SYSTEM?

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

What is the FDA product code for ANZAI AZ-733 RESPIRATORY GATING SYSTEM?

The FDA product code for ANZAI AZ-733 RESPIRATORY GATING SYSTEM is LHN.

Related Clinical Trials

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Other records listing Anzai Medical Co., 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.

K170719Anzai Respiratory Gating SystemK160432Anzai Respiratory Gating SystemK022342EZ-SCOPE AN, EZ-SCOPE LIGHT

Related Devices (Code: LHN)

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.

K260597VIRTUE QAProNova SolutionsK260174PROBEAT-CRHitachi High-Tech Corp.K252815ProBeam 360 Proton Therapy System v3.0Varian Medical Systems, Inc.K253406S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)Mevion Medical Systems, Inc.K250986S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)Mevion Medical Systems, Inc.K243900eMotus Respiratory Motion Management SystemEmpnia, Inc.

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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