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FDA 510(k)

COMBITRANS MONITORING SETS AND ACCESSORIES

K-Number: K102033 · 2011-04-07

ApplicantB.Braun Melsungen AG
Decision Date2011-04-07
Product CodeDRS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

COMBITRANS MONITORING SETS AND ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is B.Braun Melsungen AG. It received FDA 510(k) clearance on 2011-04-07 under 510(k) number K102033. The device is classified under product code DRS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMBITRANS MONITORING SETS AND ACCESSORIES?

COMBITRANS MONITORING SETS AND ACCESSORIES is a medical device that received FDA 510(k) clearance on 2011-04-07. The listed applicant is B.Braun Melsungen AG. The 510(k) number is K102033.

When did COMBITRANS MONITORING SETS AND ACCESSORIES receive FDA 510(k) clearance?

COMBITRANS MONITORING SETS AND ACCESSORIES received FDA 510(k) clearance on 2011-04-07, under 510(k) number K102033.

Who is the listed applicant for COMBITRANS MONITORING SETS AND ACCESSORIES?

The FDA 510(k) record lists B.Braun Melsungen AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COMBITRANS MONITORING SETS AND ACCESSORIES?

The FDA product code for COMBITRANS MONITORING SETS AND ACCESSORIES is DRS.

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Official Source

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