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510(k) K832288

HEMOGLOBINOMETER by Mallinckrodt Critical Care — Product Code KMG

K832288 is an FDA 510(k) premarket notification submitted by Mallinckrodt Critical Care for the device "HEMOGLOBINOMETER". The FDA issued a decision of Substantially Equivalent on September 1, 1983. The device falls under product code KMG (Purifier, Water, Ultraviolet, Medical), a Class II device regulated under 21 CFR 880.6710. Mallinckrodt Critical Care has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 1, 1983
Date Received
July 13, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Purifier, Water, Ultraviolet, Medical
Device Class
Class II
Regulation Number
880.6710
Review Panel
HO
Submission Type

Other clearances by Mallinckrodt Critical Care

  • K880343 — BURNEY GALLBLADDER CATHETER KIT (May 1, 1989)
  • K874605 — HI-LO TEMP(R) MYOCARDIAL TEMPERATURE SENSOR (February 2, 1988)
  • K874514 — HI-LO TEMP(R) GENERAL PURPOSE TEMPERATURE PROBE (January 29, 1988)
  • K874568 — HI-LO TEMP(R) MODEL 8700 PATIENT TEMP MONITOR (January 6, 1988)
  • K873461 — LASER-FLEX(TM) TRACHEAL TUBE (CUFFED) (November 6, 1987)
  • K874404 — HI-LO TEMP(R) SKIN TEMPERATURE SENSOR (November 6, 1987)
  • K873833 — THERMOCOUPLE ADAPTER (November 3, 1987)
  • K873004 — GUIDING CATHETER (September 15, 1987)
  • K871204 — CUFFED TRACHEAL TUBE (MULTIPLE) (April 21, 1987)
  • K862666 — UNCUFFED LASER RESISTEANT TRACHEAL TUBE(TENTATIVE) (August 1, 1986)

Other clearances for product code KMG

  • K012029 — REMEDY MODEL 2Z12 (December 31, 2001)
  • K831253 — LANCER HEMOGLOBIN ANALYZER REAGENTS (May 9, 1983)
  • K813050 — AQUANOMICS, #MP4SF (December 2, 1981)
  • K813048 — AQUANOMICS, #MP2SF (December 2, 1981)
  • K813047 — AQUANOMICS, MINI 60L (December 2, 1981)
  • K813045 — AQUANOMICS, #SP36SF (December 2, 1981)
  • K813049 — AQUANOMICS, #HHU100 (December 2, 1981)
  • K813046 — AQUANOMICS, #HHU60 (December 2, 1981)

FDA data resources