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FDA 510(k)

MEDIPLUS-FOAM AG; MEDIPLUS-COMFORTFOAM AG; MEDIPLUS-SUPERFOAM AG

K-Number: K110062 · 2011-09-01

ApplicantMedipurpose Pte. , Ltd.
Decision Date2011-09-01
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

MEDIPLUS-FOAM AG; MEDIPLUS-COMFORTFOAM AG; MEDIPLUS-SUPERFOAM AG is the device name listed in this FDA 510(k) record. The listed applicant is Medipurpose Pte. , Ltd.. It received FDA 510(k) clearance on 2011-09-01 under 510(k) number K110062. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDIPLUS-FOAM AG; MEDIPLUS-COMFORTFOAM AG; MEDIPLUS-SUPERFOAM AG?

MEDIPLUS-FOAM AG; MEDIPLUS-COMFORTFOAM AG; MEDIPLUS-SUPERFOAM AG is a medical device that received FDA 510(k) clearance on 2011-09-01. The listed applicant is Medipurpose Pte. , Ltd.. The 510(k) number is K110062.

When did MEDIPLUS-FOAM AG; MEDIPLUS-COMFORTFOAM AG; MEDIPLUS-SUPERFOAM AG receive FDA 510(k) clearance?

MEDIPLUS-FOAM AG; MEDIPLUS-COMFORTFOAM AG; MEDIPLUS-SUPERFOAM AG received FDA 510(k) clearance on 2011-09-01, under 510(k) number K110062.

Who is the listed applicant for MEDIPLUS-FOAM AG; MEDIPLUS-COMFORTFOAM AG; MEDIPLUS-SUPERFOAM AG?

The FDA 510(k) record lists Medipurpose Pte. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MEDIPLUS-FOAM AG; MEDIPLUS-COMFORTFOAM AG; MEDIPLUS-SUPERFOAM AG?

The FDA product code for MEDIPLUS-FOAM AG; MEDIPLUS-COMFORTFOAM AG; MEDIPLUS-SUPERFOAM AG is FRO. This falls under the Anesthesiology category.

Related Clinical Trials

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Other records listing Medipurpose Pte. , Ltd. 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.

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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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