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FDA 510(k)

BILI-THERAPY SPOT TYPE

K-Number: K103828 · 2011-03-29

ApplicantAtom Medical Corporation
Decision Date2011-03-29
Product CodeLBI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BILI-THERAPY SPOT TYPE is the device name listed in this FDA 510(k) record. The listed applicant is Atom Medical Corporation. It received FDA 510(k) clearance on 2011-03-29 under 510(k) number K103828. 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 BILI-THERAPY SPOT TYPE?

BILI-THERAPY SPOT TYPE is a medical device that received FDA 510(k) clearance on 2011-03-29. The listed applicant is Atom Medical Corporation. The 510(k) number is K103828.

When did BILI-THERAPY SPOT TYPE receive FDA 510(k) clearance?

BILI-THERAPY SPOT TYPE received FDA 510(k) clearance on 2011-03-29, under 510(k) number K103828.

Who is the listed applicant for BILI-THERAPY SPOT TYPE?

The FDA 510(k) record lists Atom Medical Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BILI-THERAPY SPOT TYPE?

The FDA product code for BILI-THERAPY SPOT TYPE is LBI.

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Other records listing Atom Medical Corporation 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.

K123937ATOM TRANSCAPSULE V-707K120937SUNFLOWER WARNERK111547BILI-THERAPY PAD TYPEK103317RESUSCITATION UNIT 105K102542RESUSCI FLOW; RESUSCI FLOW 104K102227INFA WARMER I

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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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