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510(k) K021622

HILL-ROM AIR SHIELDS/MINOLTA JAUNDICE METER, MODEL JM-103 by Hill-Rom Air-Shields — Product Code MQM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 1, 2003
Date Received
May 16, 2002
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 Hill-Rom Air-Shields

  • K003335 — RESUSCITAIRE RADIANT WARMER; RESUSCITAIRE BIRTHING ROOM WARMER; RESUSCITAIR WALL (November 17, 2000)
  • K001242 — ISOLETTE INFANT INCUBATOR, MODEL C2HS (July 13, 2000)
  • K001019 — TI500 GLOBE-TROTTER TRANSPORT SYSTEM (April 27, 2000)
  • K993051 — VERSALET 7700 CARE CENTER, MODEL # 7700 (February 3, 2000)

Other clearances for product code MQM

  • K170882 — ABL90 FLEX, ABL90 FLEX PLUS (April 28, 2017)
  • K132691 — ABL90 FLEX (November 13, 2014)
  • K133175 — DRAEGER JAUNDICE METER JM-105 (November 13, 2014)
  • K110277 — RAPIDPOINT 405 NEONATAL BILIRUBIN (August 15, 2011)
  • K073537 — NEONATAL BILIRUBIN ON RAPIDLAB MODELS 1245 AND 1265 (June 27, 2008)
  • K042522 — JAUNDICE METER, MODEL JM 103 (July 6, 2005)
  • K040174 — BILIRUBIN ASSAY ON THE OMNI S ANALYZER (May 14, 2004)
  • 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)