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FDA 510(k)

CALYPSO 4D LOCALIZATION SYSTEM

K-Number: K080726 · 2008-05-14

ApplicantCalypso Medical Technologies, Inc.
Decision Date2008-05-14
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CALYPSO 4D LOCALIZATION SYSTEM 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 2008-05-14 under 510(k) number K080726. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CALYPSO 4D LOCALIZATION SYSTEM?

CALYPSO 4D LOCALIZATION SYSTEM is a medical device that received FDA 510(k) clearance on 2008-05-14. The listed applicant is Calypso Medical Technologies, Inc.. The 510(k) number is K080726.

When did CALYPSO 4D LOCALIZATION SYSTEM receive FDA 510(k) clearance?

CALYPSO 4D LOCALIZATION SYSTEM received FDA 510(k) clearance on 2008-05-14, under 510(k) number K080726.

Who is the listed applicant for CALYPSO 4D LOCALIZATION SYSTEM?

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 4D LOCALIZATION SYSTEM?

The FDA product code for CALYPSO 4D LOCALIZATION SYSTEM is IYE.

Related Clinical Trials

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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 GATINGK102373CALYPSO SYSTEM WITH DYNAMIC EDGE GATINGK060906CALYPSO 4D LOCALIZATION SYSTEM

Related Devices (Code: IYE)

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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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