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510(k) K972309

JM-102 JAUNDICE METER by Air-Shields, Inc. — Product Code MQM

K972309 is an FDA 510(k) premarket notification submitted by Air-Shields, Inc. for the device "JM-102 JAUNDICE METER". The FDA issued a decision of Substantially Equivalent on September 22, 1998. 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. Air-Shields, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 22, 1998
Date Received
June 20, 1997
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 Air-Shields, Inc.

  • K974248 — WATCHCHILD OBSTERICAL PATIENT DATA MANAGEMENT SYSTEM (October 7, 1998)
  • K971256 — DUO-LITE PHOTOTHERAPY SYSTEM (September 24, 1997)
  • K960980 — ISOLETTE INFANT INCUBATOR (July 30, 1996)
  • K924709 — SATCARE OXYGEN CONTROLLER/MONITOR W/ PULSE OXIMETE (January 17, 1996)
  • K940951 — RW RESUCITAIRE INFANT RADIANT WARMER (May 3, 1995)
  • K940975 — C450/C400 INFANT INCUBATORS (June 23, 1994)
  • K941106 — MODEL TI500 ISOLETTE INFANT INCUBATOR (June 10, 1994)
  • K924170 — ISOLETTE INCUBATOR HUMIDITY METER (February 5, 1993)
  • K922150 — EXAMINATION LAMP (July 21, 1992)
  • K914864 — MODELS C500/C550 ISOLETE(R) INFANT INCUBATOR (March 13, 1992)

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)
  • 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)

FDA data resources