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FDA 510(k)

INFANT PHOTOTHERAPY LIGHT

K-Number: K813188 · 1981-12-09

ApplicantMontrose Phototherapy Supply
Decision Date1981-12-09
Product CodeLBI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

INFANT PHOTOTHERAPY LIGHT is the device name listed in this FDA 510(k) record. The listed applicant is Montrose Phototherapy Supply. It received FDA 510(k) clearance on 1981-12-09 under 510(k) number K813188. 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 INFANT PHOTOTHERAPY LIGHT?

INFANT PHOTOTHERAPY LIGHT is a medical device that received FDA 510(k) clearance on 1981-12-09. The listed applicant is Montrose Phototherapy Supply. The 510(k) number is K813188.

When did INFANT PHOTOTHERAPY LIGHT receive FDA 510(k) clearance?

INFANT PHOTOTHERAPY LIGHT received FDA 510(k) clearance on 1981-12-09, under 510(k) number K813188.

Who is the listed applicant for INFANT PHOTOTHERAPY LIGHT?

The FDA 510(k) record lists Montrose Phototherapy Supply as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INFANT PHOTOTHERAPY LIGHT?

The FDA product code for INFANT PHOTOTHERAPY LIGHT is LBI.

Related Clinical Trials

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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Other records listing Montrose Phototherapy Supply 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.

K813214INFANT PHOTOTHERAPY MASK

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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