Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

BRIGHT EMBRACE MODEL SBL60

K-Number: K110550 · 2012-02-03

ApplicantPhysician Engineered Products, Inc.
Decision Date2012-02-03
Product CodeLBI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BRIGHT EMBRACE MODEL SBL60 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 2012-02-03 under 510(k) number K110550. 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 BRIGHT EMBRACE MODEL SBL60?

BRIGHT EMBRACE MODEL SBL60 is a medical device that received FDA 510(k) clearance on 2012-02-03. The listed applicant is Physician Engineered Products, Inc.. The 510(k) number is K110550.

When did BRIGHT EMBRACE MODEL SBL60 receive FDA 510(k) clearance?

BRIGHT EMBRACE MODEL SBL60 received FDA 510(k) clearance on 2012-02-03, under 510(k) number K110550.

Who is the listed applicant for BRIGHT EMBRACE MODEL SBL60?

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 BRIGHT EMBRACE MODEL SBL60?

The FDA product code for BRIGHT EMBRACE MODEL SBL60 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

K093618BILI-MIRROR MODEL BLM-1K974830ULTRA BILI LIGHTK883818MODIFIED REFLUX REDUCERK882291RETROFIT BABY FACE SHIELD (RFS)K882278RESUSCITATION BAG CONTROLLER (RBC)K873700INSTITUTIONAL BILI LIGHT (IBL)

View all 8 devices →

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.

↑