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FDA 510(k)

GIRAFFE BLUE SPOT PT LITE

K-Number: K120820 · 2012-06-08

ApplicantLumitex, Inc.
Decision Date2012-06-08
Product CodeLBI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

GIRAFFE BLUE SPOT PT LITE is the device name listed in this FDA 510(k) record. The listed applicant is Lumitex, Inc.. It received FDA 510(k) clearance on 2012-06-08 under 510(k) number K120820. 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 GIRAFFE BLUE SPOT PT LITE?

GIRAFFE BLUE SPOT PT LITE is a medical device that received FDA 510(k) clearance on 2012-06-08. The listed applicant is Lumitex, Inc.. The 510(k) number is K120820.

When did GIRAFFE BLUE SPOT PT LITE receive FDA 510(k) clearance?

GIRAFFE BLUE SPOT PT LITE received FDA 510(k) clearance on 2012-06-08, under 510(k) number K120820.

Who is the listed applicant for GIRAFFE BLUE SPOT PT LITE?

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

What is the FDA product code for GIRAFFE BLUE SPOT PT LITE?

The FDA product code for GIRAFFE BLUE SPOT PT LITE is LBI.

Related Clinical Trials

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Other records listing Lumitex, Inc. 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.

K053568BILISOFT PHOTOTHERAPY SYSTEMK912747LULMITEX NEONATAL TRANSILLUMINATOR

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

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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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