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FDA 510(k)

MEDILED MINI

K-Number: K103735 · 2011-08-15

ApplicantMedix I.C.S.A.
Decision Date2011-08-15
Product CodeLBI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MEDILED MINI is the device name listed in this FDA 510(k) record. The listed applicant is Medix I.C.S.A.. It received FDA 510(k) clearance on 2011-08-15 under 510(k) number K103735. The device is classified under product code LBI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDILED MINI?

MEDILED MINI is a medical device that received FDA 510(k) clearance on 2011-08-15. The listed applicant is Medix I.C.S.A.. The 510(k) number is K103735.

When did MEDILED MINI receive FDA 510(k) clearance?

MEDILED MINI received FDA 510(k) clearance on 2011-08-15, under 510(k) number K103735.

Who is the listed applicant for MEDILED MINI?

The FDA 510(k) record lists Medix I.C.S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MEDILED MINI?

The FDA product code for MEDILED MINI is LBI.

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Other records listing Medix I.C.S.A. 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.

K083179MEDILED PHOTOTHERAPY LAMPK070291MEDIX NATAL CARE INTENSIVE CARE INCUBATOR, MODELS-NATAL CARE ST-MX/LX/BXK931529INFANT WARMERK931965MEDIX PHOTOTHERAPY LAMPK920049MEDIX PC-305 NEONATAL INCUBATOR

Related Devices (Code: LBI)

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

View on FDA Database →

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

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