FDA 510(k)

CARDIAC OUTPUT KIT, MODEL CO-1 & INLINE SENSOR CABLE, MODEL ILS-1

K-Number: K022004 · 2003-03-12

Decision Date2003-03-12

Product CodeDQO

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

CARDIAC OUTPUT KIT, MODEL CO-1 & INLINE SENSOR CABLE, MODEL ILS-1 is the device name listed in this FDA 510(k) record. The listed applicant is Biosensors International-USA. It received FDA 510(k) clearance on 2003-03-12 under 510(k) number K022004. The device is classified under product code DQO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIAC OUTPUT KIT, MODEL CO-1 & INLINE SENSOR CABLE, MODEL ILS-1?

CARDIAC OUTPUT KIT, MODEL CO-1 & INLINE SENSOR CABLE, MODEL ILS-1 is a medical device that received FDA 510(k) clearance on 2003-03-12. The listed applicant is Biosensors International-USA. The 510(k) number is K022004.

When did CARDIAC OUTPUT KIT, MODEL CO-1 & INLINE SENSOR CABLE, MODEL ILS-1 receive FDA 510(k) clearance?

CARDIAC OUTPUT KIT, MODEL CO-1 & INLINE SENSOR CABLE, MODEL ILS-1 received FDA 510(k) clearance on 2003-03-12, under 510(k) number K022004.

Who is the listed applicant for CARDIAC OUTPUT KIT, MODEL CO-1 & INLINE SENSOR CABLE, MODEL ILS-1?

The FDA 510(k) record lists Biosensors International-USA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CARDIAC OUTPUT KIT, MODEL CO-1 & INLINE SENSOR CABLE, MODEL ILS-1?

The FDA product code for CARDIAC OUTPUT KIT, MODEL CO-1 & INLINE SENSOR CABLE, MODEL ILS-1 is DQO.

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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.