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FDA 510(k)

KION ANAESTHESIA SYSTEM, MODEL 65 03 879 E392E

K-Number: K010923 · 2002-01-23

ApplicantSiemens Elema AB
Decision Date2002-01-23
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

KION ANAESTHESIA SYSTEM, MODEL 65 03 879 E392E is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Elema AB. It received FDA 510(k) clearance on 2002-01-23 under 510(k) number K010923. The device is classified under product code MHX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KION ANAESTHESIA SYSTEM, MODEL 65 03 879 E392E?

KION ANAESTHESIA SYSTEM, MODEL 65 03 879 E392E is a medical device that received FDA 510(k) clearance on 2002-01-23. The listed applicant is Siemens Elema AB. The 510(k) number is K010923.

When did KION ANAESTHESIA SYSTEM, MODEL 65 03 879 E392E receive FDA 510(k) clearance?

KION ANAESTHESIA SYSTEM, MODEL 65 03 879 E392E received FDA 510(k) clearance on 2002-01-23, under 510(k) number K010923.

Who is the listed applicant for KION ANAESTHESIA SYSTEM, MODEL 65 03 879 E392E?

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

What is the FDA product code for KION ANAESTHESIA SYSTEM, MODEL 65 03 879 E392E?

The FDA product code for KION ANAESTHESIA SYSTEM, MODEL 65 03 879 E392E is MHX.

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Other records listing Siemens Elema AB 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.

K023354COMPRESSOR MINI, 115 V, MODEL 64 81 779 EH81EK010925SERVOI VENTILATOR SYSTEM, MODEL 64 87 800 E407EK002137CATHCOR DESKTOPK001315MODIFICATION TO KION ANESTHESIA SYSTEMK970839SERVO VENTILATOR 300AK960010SERVO VENTILATOR 300 COMPUTER INTERFACE

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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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