Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

KOZY COMFORT INFANT POSITIONER

K-Number: K062143 · 2006-10-24

ApplicantAlfred E Mann Inst. For Biomedical Engineering
Decision Date2006-10-24
Product CodeFRP
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

KOZY COMFORT INFANT POSITIONER is the device name listed in this FDA 510(k) record. The listed applicant is Alfred E Mann Inst. For Biomedical Engineering. It received FDA 510(k) clearance on 2006-10-24 under 510(k) number K062143. 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 KOZY COMFORT INFANT POSITIONER?

KOZY COMFORT INFANT POSITIONER is a medical device that received FDA 510(k) clearance on 2006-10-24. The listed applicant is Alfred E Mann Inst. For Biomedical Engineering. The 510(k) number is K062143.

When did KOZY COMFORT INFANT POSITIONER receive FDA 510(k) clearance?

KOZY COMFORT INFANT POSITIONER received FDA 510(k) clearance on 2006-10-24, under 510(k) number K062143.

Who is the listed applicant for KOZY COMFORT INFANT POSITIONER?

The FDA 510(k) record lists Alfred E Mann Inst. For Biomedical Engineering as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KOZY COMFORT INFANT POSITIONER?

The FDA product code for KOZY COMFORT INFANT POSITIONER is FRP.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

K082367INFANT SLEEP BEANIELife Innovations, LLCK090284RES-Q INFANT WEDGE AND SLINGCr Enterprises, LLCK060986HEAD BEDSteven H. Warnock, M.D.K051300ROBIN HOOD VESTKamber CorporationK041996NIGHTFORMPlastic Surgery Solutions, LLCK003511KENDALL-LTP TURNER SAVE-A-LINEThe Ludlow Company LP

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.

↑