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510(k) K252383

Somfit D by Compumedics Limited — Product Code MNR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 28, 2025
Date Received
July 31, 2025
Clearance Type
Special
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Ventilatory Effort Recorder
Device Class
Class II
Regulation Number
868.2375
Review Panel
AN
Submission Type

Other clearances by Compumedics Limited

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  • K093223 — COMPUMEDICS GRAEL SYSTEM, MODELS: GRAEL, GRAEL ECG (January 15, 2010)
  • K072201 — COMPUMEDICS SOMTE PSG RECORDING SYSTEM (April 14, 2008)
  • K021176 — COMPUMEDICS SOMTE SYSTEM (January 21, 2003)
  • K003175 — COMPUMEDICS SIESTA SYSTEM (December 27, 2000)

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