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FDA 510(k)

MEDILED PHOTOTHERAPY LAMP

K-Number: K083179 · 2009-02-27

ApplicantMedix I.C.S.A.
Decision Date2009-02-27
Product CodeLBI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MEDILED PHOTOTHERAPY LAMP 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 2009-02-27 under 510(k) number K083179. 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 PHOTOTHERAPY LAMP?

MEDILED PHOTOTHERAPY LAMP is a medical device that received FDA 510(k) clearance on 2009-02-27. The listed applicant is Medix I.C.S.A.. The 510(k) number is K083179.

When did MEDILED PHOTOTHERAPY LAMP receive FDA 510(k) clearance?

MEDILED PHOTOTHERAPY LAMP received FDA 510(k) clearance on 2009-02-27, under 510(k) number K083179.

Who is the listed applicant for MEDILED PHOTOTHERAPY LAMP?

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 PHOTOTHERAPY LAMP?

The FDA product code for MEDILED PHOTOTHERAPY LAMP 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.

K103735MEDILED MINIK070291MEDIX 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.

K251308SnugLit(TM) Wearable Phototherapy System (SNGL-01-US)Thera B Medical ProductsK243372BiliWrapGerium Medical, Ltd.K210289Infant Phototherapy EquipmentBistos Co., Ltd.K200031Neonatal Phototherapy SystemAvalon Biomedical (Shenzhen) LimitedK190899bili-hutLittle Sparrows Technologies, Inc.K182178neoBLUE blanket LED Phototherapy SystemNatus Medical Incorporated

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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