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FDA 510(k)

MEDISIZE BLUE, MEDISIZE GREEN, MEDISIZE RED

K-Number: K081536 · 2009-01-23

ApplicantMedisize BV
Decision Date2009-01-23
Product CodeCAH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MEDISIZE BLUE, MEDISIZE GREEN, MEDISIZE RED is the device name listed in this FDA 510(k) record. The listed applicant is Medisize BV. It received FDA 510(k) clearance on 2009-01-23 under 510(k) number K081536. 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 BLUE, MEDISIZE GREEN, MEDISIZE RED?

MEDISIZE BLUE, MEDISIZE GREEN, MEDISIZE RED is a medical device that received FDA 510(k) clearance on 2009-01-23. The listed applicant is Medisize BV. The 510(k) number is K081536.

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

MEDISIZE BLUE, MEDISIZE GREEN, MEDISIZE RED received FDA 510(k) clearance on 2009-01-23, under 510(k) number K081536.

Who is the listed applicant for MEDISIZE BLUE, MEDISIZE GREEN, MEDISIZE RED?

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

What is the FDA product code for MEDISIZE BLUE, MEDISIZE GREEN, MEDISIZE RED?

The FDA product code for MEDISIZE BLUE, MEDISIZE GREEN, MEDISIZE RED is CAH.

Related Clinical Trials

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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Other records listing Medisize BV 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.

K122885MEDISIZE GOLD HEATER AND BOOSTER T-PIECEK070714MEDISIZE GOLD HEATER AND BOOSTERK052615MEDISIZE GOLD

Related Devices (Code: CAH)

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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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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