FDA 510(k)

bili-hut

K-Number: K190899 · 2019-09-05

ApplicantLittle Sparrows Technologies, Inc.

Decision Date2019-09-05

Product CodeLBI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

bili-hut is the device name listed in this FDA 510(k) record. The listed applicant is Little Sparrows Technologies, Inc.. It received FDA 510(k) clearance on 2019-09-05 under 510(k) number K190899. 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 bili-hut?

bili-hut is a medical device that received FDA 510(k) clearance on 2019-09-05. The listed applicant is Little Sparrows Technologies, Inc.. The 510(k) number is K190899.

When did bili-hut receive FDA 510(k) clearance?

bili-hut received FDA 510(k) clearance on 2019-09-05, under 510(k) number K190899.

Who is the listed applicant for bili-hut?

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

What is the FDA product code for bili-hut?

The FDA product code for bili-hut is LBI.

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 Products K243372BiliWrapGerium Medical, Ltd.K210289Infant Phototherapy EquipmentBistos Co., Ltd.K200031Neonatal Phototherapy SystemAvalon Biomedical (Shenzhen) Limited K182178neoBLUE blanket LED Phototherapy SystemNatus Medical Incorporated K172656BiliLuxDraeger Medical Systems, Inc.

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.