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FDA 510(k)

INSTITUTIONAL BILI LIGHT (IBL)

K-Number: K873700 · 1987-12-11

ApplicantPhysician Engineered Products, Inc.
Decision Date1987-12-11
Product CodeLBI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

INSTITUTIONAL BILI LIGHT (IBL) is the device name listed in this FDA 510(k) record. The listed applicant is Physician Engineered Products, Inc.. It received FDA 510(k) clearance on 1987-12-11 under 510(k) number K873700. 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 INSTITUTIONAL BILI LIGHT (IBL)?

INSTITUTIONAL BILI LIGHT (IBL) is a medical device that received FDA 510(k) clearance on 1987-12-11. The listed applicant is Physician Engineered Products, Inc.. The 510(k) number is K873700.

When did INSTITUTIONAL BILI LIGHT (IBL) receive FDA 510(k) clearance?

INSTITUTIONAL BILI LIGHT (IBL) received FDA 510(k) clearance on 1987-12-11, under 510(k) number K873700.

Who is the listed applicant for INSTITUTIONAL BILI LIGHT (IBL)?

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

What is the FDA product code for INSTITUTIONAL BILI LIGHT (IBL)?

The FDA product code for INSTITUTIONAL BILI LIGHT (IBL) is LBI.

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Other records listing Physician Engineered Products, 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.

K110550BRIGHT EMBRACE MODEL SBL60K093618BILI-MIRROR MODEL BLM-1K974830ULTRA BILI LIGHTK883818MODIFIED REFLUX REDUCERK882291RETROFIT BABY FACE SHIELD (RFS)K882278RESUSCITATION BAG CONTROLLER (RBC)

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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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