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FDA 510(k) Applications Submitted by COMPUMEDICS LIMITED
FDA 510(k) Number
Submission Date
Device Name
Applicant
K003175
10/10/2000
COMPUMEDICS SIESTA SYSTEM
COMPUMEDICS LIMITED
K021176
04/12/2002
COMPUMEDICS SOMTE SYSTEM
COMPUMEDICS LIMITED
K072201
08/08/2007
COMPUMEDICS SOMTE PSG RECORDING SYSTEM
COMPUMEDICS LIMITED
K230073
01/10/2023
Okti
Compumedics Limited
K093223
10/13/2009
COMPUMEDICS GRAEL SYSTEM, MODELS: GRAEL, GRAEL ECG
COMPUMEDICS LIMITED
K191785
07/03/2019
Orion LifeSpan MEG
Compumedics Limited
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