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FDA 510(k)

PRECIOUS LITE MODEL 4224

K-Number: K854122 · 1986-02-07

ApplicantE & B Technologies, Inc.
Decision Date1986-02-07
Product CodeLBI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PRECIOUS LITE MODEL 4224 is the device name listed in this FDA 510(k) record. The listed applicant is E & B Technologies, Inc.. It received FDA 510(k) clearance on 1986-02-07 under 510(k) number K854122. 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 PRECIOUS LITE MODEL 4224?

PRECIOUS LITE MODEL 4224 is a medical device that received FDA 510(k) clearance on 1986-02-07. The listed applicant is E & B Technologies, Inc.. The 510(k) number is K854122.

When did PRECIOUS LITE MODEL 4224 receive FDA 510(k) clearance?

PRECIOUS LITE MODEL 4224 received FDA 510(k) clearance on 1986-02-07, under 510(k) number K854122.

Who is the listed applicant for PRECIOUS LITE MODEL 4224?

The FDA 510(k) record lists E & B Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PRECIOUS LITE MODEL 4224?

The FDA product code for PRECIOUS LITE MODEL 4224 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 E & B Technologies, 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.

K892940PRECIOUS LITE MODEL 4224

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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