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FDA 510(k)

LULLABY LED PHOTTHERAPY SYSTEM

K-Number: K120168 · 2012-05-02

ApplicantWipro GE Healthcare Private, Ltd.
Decision Date2012-05-02
Product CodeLBI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

LULLABY LED PHOTTHERAPY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Wipro GE Healthcare Private, Ltd.. It received FDA 510(k) clearance on 2012-05-02 under 510(k) number K120168. 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 LULLABY LED PHOTTHERAPY SYSTEM?

LULLABY LED PHOTTHERAPY SYSTEM is a medical device that received FDA 510(k) clearance on 2012-05-02. The listed applicant is Wipro GE Healthcare Private, Ltd.. The 510(k) number is K120168.

When did LULLABY LED PHOTTHERAPY SYSTEM receive FDA 510(k) clearance?

LULLABY LED PHOTTHERAPY SYSTEM received FDA 510(k) clearance on 2012-05-02, under 510(k) number K120168.

Who is the listed applicant for LULLABY LED PHOTTHERAPY SYSTEM?

The FDA 510(k) record lists Wipro GE Healthcare Private, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LULLABY LED PHOTTHERAPY SYSTEM?

The FDA product code for LULLABY LED PHOTTHERAPY SYSTEM is LBI.

Related Clinical Trials

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Other records listing Wipro GE Healthcare Private, Ltd. 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.

K1236811.5T 4CH LARGE FLEX COIL, 1.5 4CH SMALL FLEX COILK121625LULLABY TM WARMERK110556MINI TELEMETRY SYSTEMK102104GE VIVID P3 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM

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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