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FDA 510(k)

RPI REPLACEMENT PHOTOTHERAPY LIGHTS

K-Number: K021531 · 2002-05-31

ApplicantReplacement Parts Industries, Inc.
Decision Date2002-05-31
Product CodeLBI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

RPI REPLACEMENT PHOTOTHERAPY LIGHTS is the device name listed in this FDA 510(k) record. The listed applicant is Replacement Parts Industries, Inc.. It received FDA 510(k) clearance on 2002-05-31 under 510(k) number K021531. 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 RPI REPLACEMENT PHOTOTHERAPY LIGHTS?

RPI REPLACEMENT PHOTOTHERAPY LIGHTS is a medical device that received FDA 510(k) clearance on 2002-05-31. The listed applicant is Replacement Parts Industries, Inc.. The 510(k) number is K021531.

When did RPI REPLACEMENT PHOTOTHERAPY LIGHTS receive FDA 510(k) clearance?

RPI REPLACEMENT PHOTOTHERAPY LIGHTS received FDA 510(k) clearance on 2002-05-31, under 510(k) number K021531.

Who is the listed applicant for RPI REPLACEMENT PHOTOTHERAPY LIGHTS?

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

What is the FDA product code for RPI REPLACEMENT PHOTOTHERAPY LIGHTS?

The FDA product code for RPI REPLACEMENT PHOTOTHERAPY LIGHTS is LBI.

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Other records listing Replacement Parts Industries, 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.

K020966RPI REPLACEMENT HEATING ELEMENTSK020219RPI SKIN OR AIR TEMPERATURE PROBE

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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