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FDA 510(k)

MEDISIZE RED AND MEDISIZE BLUE

K-Number: K110246 · 2011-11-04

ApplicantQserve America, Inc.
Decision Date2011-11-04
Product CodeCAH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MEDISIZE RED AND MEDISIZE BLUE is the device name listed in this FDA 510(k) record. The listed applicant is Qserve America, Inc.. It received FDA 510(k) clearance on 2011-11-04 under 510(k) number K110246. The device is classified under product code CAH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDISIZE RED AND MEDISIZE BLUE?

MEDISIZE RED AND MEDISIZE BLUE is a medical device that received FDA 510(k) clearance on 2011-11-04. The listed applicant is Qserve America, Inc.. The 510(k) number is K110246.

When did MEDISIZE RED AND MEDISIZE BLUE receive FDA 510(k) clearance?

MEDISIZE RED AND MEDISIZE BLUE received FDA 510(k) clearance on 2011-11-04, under 510(k) number K110246.

Who is the listed applicant for MEDISIZE RED AND MEDISIZE BLUE?

The FDA 510(k) record lists Qserve America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MEDISIZE RED AND MEDISIZE BLUE?

The FDA product code for MEDISIZE RED AND MEDISIZE BLUE is CAH.

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Other records listing Qserve America, Inc. 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.

K123514CLEARPATH ALIGNER

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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.

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Official Source

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