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510(k) K043512

EASYGLUCO IGM-0002 G2 by American Healthcare, Inc. — Product Code CGA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 2005
Date Received
December 20, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Glucose Oxidase, Glucose
Device Class
Class II
Regulation Number
862.1345
Review Panel
CH
Submission Type

Other clearances by American Healthcare, Inc.

  • K043543 — BLOOD GLUCOSE MONITORING SYSTEM (April 8, 2005)
  • K031501 — EASYGLUCO, MODEL IGM0002 (October 16, 2003)
  • K924192 — I.V. START KIT (AHC-50-54954 (August 27, 1993)
  • K923939 — IRRIGATION TRAY W/ BULB SYRINGE & STERILE WATER (June 17, 1993)
  • K923938 — IRRIGATION TRAY W/ PISTON SYRINGE & STERILE WATER (June 17, 1993)
  • K923940 — IRRIGATION TRAY W/ PISTON SYRINGE & STERILE SALINE (June 17, 1993)
  • K923941 — IRRIGATION TRAY W/ BULB SYRINGE & STERILE SALINE (June 17, 1993)
  • K924193 — TRACHEOSTOMY CARE SET W/ HYDRO PEROX(AHC-20-54685) (June 16, 1993)
  • K924191 — TRACHEOSTOMY CARE SET WITH GLOVES AND EXTRA TOWEL (April 2, 1993)
  • K924195 — TRACHEOSTOMY CARE SET W/FORCEPS & GAUZE TRACH DRES (January 6, 1993)

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