Atlas FDA

MDZ

2 FDA 510(k) clearances · Product code

FDA profile

Official device name
Cleaners, Medical Devices
Device class
Class II (moderate risk)
Regulation
21 CFR 880.6992
Medical specialty
General Hospital
Flags
Third-party review eligible
Adverse events (MAUDE)
1996: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
DECOMAT A 8666 (K920413)Getinge International, Inc.1994-04-05
DECOMAT 228 (K920406)Getinge International, Inc.1994-04-05

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