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FDA 510(k)

BILI-THERAPY PAD TYPE

K-Number: K111547 · 2012-04-12

ApplicantAtom Medical Corporation
Decision Date2012-04-12
Product CodeLBI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BILI-THERAPY PAD 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 2012-04-12 under 510(k) number K111547. 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 PAD TYPE?

BILI-THERAPY PAD TYPE is a medical device that received FDA 510(k) clearance on 2012-04-12. The listed applicant is Atom Medical Corporation. The 510(k) number is K111547.

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

BILI-THERAPY PAD TYPE received FDA 510(k) clearance on 2012-04-12, under 510(k) number K111547.

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

The FDA product code for BILI-THERAPY PAD 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 WARNERK103317RESUSCITATION UNIT 105K102542RESUSCI FLOW; RESUSCI FLOW 104K103828BILI-THERAPY SPOT TYPEK102227INFA 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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