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510(k) K042522

JAUNDICE METER, MODEL JM 103 by Draeger Medical Infant Care, Inc. — Product Code MQM

K042522 is an FDA 510(k) premarket notification submitted by Draeger Medical Infant Care, Inc. for the device "JAUNDICE METER, MODEL JM 103". The FDA issued a decision of Substantially Equivalent on July 6, 2005. The device falls under product code MQM (Bilirubin (Total And Unbound) In The Neonate Test System), a Class I device regulated under 21 CFR 862.1113. Draeger Medical Infant Care, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 6, 2005
Date Received
September 16, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bilirubin (Total And Unbound) In The Neonate Test System
Device Class
Class I
Regulation Number
862.1113
Review Panel
CH
Submission Type

Other clearances by Draeger Medical Infant Care, Inc.

  • K053399 — VERSALET 7700 CARE CENTER (August 4, 2006)

Other clearances for product code MQM

  • K170882 — ABL90 FLEX, ABL90 FLEX PLUS (April 28, 2017)
  • K133175 — DRAEGER JAUNDICE METER JM-105 (November 13, 2014)
  • K132691 — ABL90 FLEX (November 13, 2014)
  • K110277 — RAPIDPOINT 405 NEONATAL BILIRUBIN (August 15, 2011)
  • K073537 — NEONATAL BILIRUBIN ON RAPIDLAB MODELS 1245 AND 1265 (June 27, 2008)
  • K040174 — BILIRUBIN ASSAY ON THE OMNI S ANALYZER (May 14, 2004)
  • K021622 — HILL-ROM AIR SHIELDS/MINOLTA JAUNDICE METER, MODEL JM-103 (April 1, 2003)
  • K001687 — COLORMATE TLC BILITEST SYSTEM (September 13, 2001)
  • K010052 — RESPIRONICS BILICHEK NON-INVASIVE-100-0800-20; BILIRUBIN ANALYZER (March 19, 2001)
  • K994438 — BILICHEK NON-INVASIVE BILIRUBIN ANALYZER (February 4, 2000)

FDA data resources