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510(k) K072201

COMPUMEDICS SOMTE PSG RECORDING SYSTEM by Compumedics Limited — Product Code MNR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 2008
Date Received
August 8, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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  • K021176 — COMPUMEDICS SOMTE SYSTEM (January 21, 2003)
  • K003175 — COMPUMEDICS SIESTA SYSTEM (December 27, 2000)

Other clearances for product code MNR

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  • K243220 — Onera STS 2 (ONERA STS 2) (July 3, 2025)
  • K242224 — Happy Health Home Sleep Test (June 18, 2025)
  • K243092 — AcuPebble Ox (200) (March 19, 2025)
  • K243268 — TipTraQ (TTQ001) (February 3, 2025)
  • K244027 — SANSA HSAT (January 28, 2025)
  • K242290 — DormoTech NLab (January 8, 2025)