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510(k) K071556

SOMNOSCREEN EEG10-20 by Somnomedics GmbH — Product Code MNR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 2007
Date Received
June 7, 2007
Clearance Type
Special
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

Other clearances by Somnomedics GmbH

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  • K212325 — EEG-acp (June 15, 2022)
  • K201054 — SOMNOscreen plus (August 12, 2020)
  • K140861 — SOMNOTOUCH RESP (January 30, 2015)
  • K081485 — SOMNOWATCH (September 18, 2008)

Other clearances for product code MNR

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  • K250882 — SANSA HSAT (October 29, 2025)
  • K250460 — WatchPAT400 (WP400) (September 5, 2025)
  • K252383 — Somfit D (August 28, 2025)
  • 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)