FDA 510(k)

SERVO VENTILATOR 300 COMPUTER INTERFACE

K-Number: K960010 · 1996-10-25

Decision Date1996-10-25

Product CodeCBK

Advisory CommitteeAN

DecisionSubstantially Equivalent - Subject to Tracking Reg.

Device Summary

SERVO VENTILATOR 300 COMPUTER INTERFACE 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 1996-10-25 under 510(k) number K960010. The device is classified under product code CBK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent - Subject to Tracking Reg..

Frequently Asked Questions

What is the SERVO VENTILATOR 300 COMPUTER INTERFACE?

SERVO VENTILATOR 300 COMPUTER INTERFACE is a medical device that received FDA 510(k) clearance on 1996-10-25. The listed applicant is Siemens Elema AB. The 510(k) number is K960010.

When did SERVO VENTILATOR 300 COMPUTER INTERFACE receive FDA 510(k) clearance?

SERVO VENTILATOR 300 COMPUTER INTERFACE received FDA 510(k) clearance on 1996-10-25, under 510(k) number K960010.

Who is the listed applicant for SERVO VENTILATOR 300 COMPUTER INTERFACE?

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 SERVO VENTILATOR 300 COMPUTER INTERFACE?

The FDA product code for SERVO VENTILATOR 300 COMPUTER INTERFACE is CBK.

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Other records listing Siemens Elema AB as applicant

K023354COMPRESSOR MINI, 115 V, MODEL 64 81 779 EH81E K010923KION ANAESTHESIA SYSTEM, MODEL 65 03 879 E392E K010925SERVOI VENTILATOR SYSTEM, MODEL 64 87 800 E407E K002137CATHCOR DESKTOP K001315MODIFICATION TO KION ANESTHESIA SYSTEM K970839SERVO VENTILATOR 300A

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Related Devices (Code: CBK)

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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.