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FDA 510(k)

INFANT SLEEP BEANIE

K-Number: K082367 · 2009-06-12

ApplicantLife Innovations, LLC
Decision Date2009-06-12
Product CodeFRP
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

INFANT SLEEP BEANIE is the device name listed in this FDA 510(k) record. The listed applicant is Life Innovations, LLC. It received FDA 510(k) clearance on 2009-06-12 under 510(k) number K082367. The device is classified under product code FRP. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INFANT SLEEP BEANIE?

INFANT SLEEP BEANIE is a medical device that received FDA 510(k) clearance on 2009-06-12. The listed applicant is Life Innovations, LLC. The 510(k) number is K082367.

When did INFANT SLEEP BEANIE receive FDA 510(k) clearance?

INFANT SLEEP BEANIE received FDA 510(k) clearance on 2009-06-12, under 510(k) number K082367.

Who is the listed applicant for INFANT SLEEP BEANIE?

The FDA 510(k) record lists Life Innovations, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INFANT SLEEP BEANIE?

The FDA product code for INFANT SLEEP BEANIE is FRP.

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Related Devices (Code: FRP)

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.

K090284RES-Q INFANT WEDGE AND SLINGCr Enterprises, LLCK062143KOZY COMFORT INFANT POSITIONERAlfred E Mann Inst. For Biomedical EngineeringK060986HEAD BEDSteven H. Warnock, M.D.K051300ROBIN HOOD VESTKamber CorporationK041996NIGHTFORMPlastic Surgery Solutions, LLCK003511KENDALL-LTP TURNER SAVE-A-LINEThe Ludlow Company LP

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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