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FDA 510(k)

MAM COOLER

K-Number: K093266 · 2010-07-27

ApplicantMam International AG
Decision Date2010-07-27
Product CodeKKO
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MAM COOLER is the device name listed in this FDA 510(k) record. The listed applicant is Mam International AG. It received FDA 510(k) clearance on 2010-07-27 under 510(k) number K093266. The device is classified under product code KKO. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAM COOLER?

MAM COOLER is a medical device that received FDA 510(k) clearance on 2010-07-27. The listed applicant is Mam International AG. The 510(k) number is K093266.

When did MAM COOLER receive FDA 510(k) clearance?

MAM COOLER received FDA 510(k) clearance on 2010-07-27, under 510(k) number K093266.

Who is the listed applicant for MAM COOLER?

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

What is the FDA product code for MAM COOLER?

The FDA product code for MAM COOLER is KKO.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Mam International AG 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.

K092781MAM TWISTER

Related Devices (Code: KKO)

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.

K123855WATER-FILLED TEETHERSolid Toys Ind. , Ltd.K110615WATER FILLED TEETHER, WATER FILLED TEETHER WITH HANDLEBebe Toys Manufactory , Ltd.K092025FLUID FILLED TEETHER - GELKids IIK092781MAM TWISTERMam International AGK092494GEL FILLED GUM SOOTHERLuv N' Care, Ltd.K093370FU HONG INDUSTRIES LIMITED SOOTHER TEETHERFu Hong Industries , Ltd.

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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