Clearance Summary
JAUNDICE METER, MODEL JM 103 received FDA 510(k) clearance under submission number K042522, sponsored by Draeger Medical Infant Care, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2005-07-06.
- Submission: K042522
- Applicant / Sponsor: Draeger Medical Infant Care, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1113
- Decision date: 2005-07-06
Classification & Regulation
This clearance is catalogued under FDA product code MQM and 21 CFR 862.1113, within the Clinical Chemistry review panel as a Class I device.