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FDA 510(k)

CALYPSO SYSTEM WITH DYNAMIC EDGE GATING

K-Number: K102373 · 2010-09-30

ApplicantCalypso Medical Technologies, Inc.
Decision Date2010-09-30
Product CodeLHN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CALYPSO SYSTEM WITH DYNAMIC EDGE GATING is the device name listed in this FDA 510(k) record. The listed applicant is Calypso Medical Technologies, Inc.. It received FDA 510(k) clearance on 2010-09-30 under 510(k) number K102373. 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 CALYPSO SYSTEM WITH DYNAMIC EDGE GATING?

CALYPSO SYSTEM WITH DYNAMIC EDGE GATING is a medical device that received FDA 510(k) clearance on 2010-09-30. The listed applicant is Calypso Medical Technologies, Inc.. The 510(k) number is K102373.

When did CALYPSO SYSTEM WITH DYNAMIC EDGE GATING receive FDA 510(k) clearance?

CALYPSO SYSTEM WITH DYNAMIC EDGE GATING received FDA 510(k) clearance on 2010-09-30, under 510(k) number K102373.

Who is the listed applicant for CALYPSO SYSTEM WITH DYNAMIC EDGE GATING?

The FDA 510(k) record lists Calypso Medical Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CALYPSO SYSTEM WITH DYNAMIC EDGE GATING?

The FDA product code for CALYPSO SYSTEM WITH DYNAMIC EDGE GATING is LHN.

Related Clinical Trials

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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Other records listing Calypso Medical Technologies, Inc. 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.

K112841SURFACE BEACON TRANSPONDERSK112768CALYPSO SYSTEMS WITH DYNAMIC EDGE GATINGK080726CALYPSO 4D LOCALIZATION SYSTEMK060906CALYPSO 4D LOCALIZATION SYSTEM

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

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

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