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FDA 510(k)

OLYMPIC BILI-LITE

K-Number: K940996 · 1994-09-16

ApplicantOlympic Medical Corp.
Decision Date1994-09-16
Product CodeLBI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

OLYMPIC BILI-LITE is the device name listed in this FDA 510(k) record. The listed applicant is Olympic Medical Corp.. It received FDA 510(k) clearance on 1994-09-16 under 510(k) number K940996. 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 OLYMPIC BILI-LITE?

OLYMPIC BILI-LITE is a medical device that received FDA 510(k) clearance on 1994-09-16. The listed applicant is Olympic Medical Corp.. The 510(k) number is K940996.

When did OLYMPIC BILI-LITE receive FDA 510(k) clearance?

OLYMPIC BILI-LITE received FDA 510(k) clearance on 1994-09-16, under 510(k) number K940996.

Who is the listed applicant for OLYMPIC BILI-LITE?

The FDA 510(k) record lists Olympic Medical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OLYMPIC BILI-LITE?

The FDA product code for OLYMPIC BILI-LITE is LBI.

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Other records listing Olympic Medical Corp. 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.

K081094OLYMPIC PASTEURMATIC, MODELS 3000 AND 3500K031149OLYMPIC CFM 6000K020335OLYMPIC MEDICAL LECTROMED CEREBRAL FUNCTION MONITOR SYSTEM, MODEL 5330K001056OLYMPIC WARM-UPK983229OLYMPIC MEDICAL LECTROMED CEREBRAL FUNCTION MONITOR SYSTEMK971601OLYMPIC BILI-BASSINET

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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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