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FDA 510(k)

MEDXPERT P.E.S. (PECTUS EXACVATUM SYSTEM), MEDXPERT STRATOS

K-Number: K073556 · 2008-06-24

ApplicantMedxpert GmbH
Decision Date2008-06-24
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MEDXPERT P.E.S. (PECTUS EXACVATUM SYSTEM), MEDXPERT STRATOS is the device name listed in this FDA 510(k) record. The listed applicant is Medxpert GmbH. It received FDA 510(k) clearance on 2008-06-24 under 510(k) number K073556. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDXPERT P.E.S. (PECTUS EXACVATUM SYSTEM), MEDXPERT STRATOS?

MEDXPERT P.E.S. (PECTUS EXACVATUM SYSTEM), MEDXPERT STRATOS is a medical device that received FDA 510(k) clearance on 2008-06-24. The listed applicant is Medxpert GmbH. The 510(k) number is K073556.

When did MEDXPERT P.E.S. (PECTUS EXACVATUM SYSTEM), MEDXPERT STRATOS receive FDA 510(k) clearance?

MEDXPERT P.E.S. (PECTUS EXACVATUM SYSTEM), MEDXPERT STRATOS received FDA 510(k) clearance on 2008-06-24, under 510(k) number K073556.

Who is the listed applicant for MEDXPERT P.E.S. (PECTUS EXACVATUM SYSTEM), MEDXPERT STRATOS?

The FDA 510(k) record lists Medxpert GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MEDXPERT P.E.S. (PECTUS EXACVATUM SYSTEM), MEDXPERT STRATOS?

The FDA product code for MEDXPERT P.E.S. (PECTUS EXACVATUM SYSTEM), MEDXPERT STRATOS is HRS.

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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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