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510(k) K920413

DECOMAT A 8666 by Getinge International, Inc. — Product Code MDZ

K920413 is an FDA 510(k) premarket notification submitted by Getinge International, Inc. for the device "DECOMAT A 8666". The FDA issued a decision of Substantially Equivalent on April 5, 1994. The device falls under product code MDZ (Cleaners, Medical Devices), a Class II device regulated under 21 CFR 880.6992. Getinge International, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 5, 1994
Date Received
January 31, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cleaners, Medical Devices
Device Class
Class II
Regulation Number
880.6992
Review Panel
HO
Submission Type

Other clearances by Getinge International, Inc.

  • K920406 — DECOMAT 228 (April 5, 1994)
  • K821842 — GAS STERILIZATION EQUIPMENT (July 28, 1982)
  • K821591 — STEAM STERILIZATION EQUIPMENT (June 22, 1982)

Other clearances for product code MDZ

  • K920406 — DECOMAT 228 (April 5, 1994)

FDA data resources