JAUNDICE METER, MODEL JM 103— 510(k) K042522

Name: FDA 510(k) clearance K042522
Creator: U.S. Food and Drug Administration
Published: 2005-07-06

Substantially Equivalent

Draeger Medical Infant Care, Inc.

FDA 510(k) clearance K042522 for JAUNDICE METER, MODEL JM 103, Substantially Equivalent on 2005-07-06. Applicant: Draeger Medical Infant Care, Inc.. Device class: 1.

Clearance details

Applicant: Draeger Medical Infant Care, Inc.
Product code: Code MQM
Device class: Class 1
Regulation: 21 CFR 862.1113
Advisory panel: Clinical Chemistry
Date received: 2004-09-16
Decision date: 2005-07-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hatboro, PA, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K042522

K-number listed on FDA's recall record

Z-2046-2018 — Draeger Jaundice Meter JM-103 The device is intended for use in hospitals, clinics or doctor s offices under a physician s supervision / direction to assist clinicians in monitoring of newborn infants. The device is not intended as a standalone for diagnosis of hyperbilirubinemia. It is to be used in conjunction with other clinical signs and laboratory measurements. The Jaundice Meter is not intended for home use. The Jaundice Meter may only be used at the sternum measurement site for Physician s office applicationsClass I·Terminated·Draeger Medical Systems, Inc.·20180515

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K042522.

Data sourced from openFDA. This site is unofficial and independent of the FDA.