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Jaundice Meter, Model Jm 103

by Draeger Medical Infant Care, Inc.

510(k) K042522

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK042522 Date6 Jul 2005ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-2046-2018 FDA Class I initiated 15 May 2018

    Users have misinterpreted the display for out of range measurement indicated by the blinking" ---" to mean a zero measurement.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
MQM
Device Class
Class I
Regulation
21 CFR Part 862.1113
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

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