Home / 510(k) Clearances / K021176

510(k) K021176

COMPUMEDICS SOMTE SYSTEM by Compumedics Limited — Product Code MNR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 21, 2003
Date Received
April 12, 2002
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

Other clearances by Compumedics Limited

  • K252383 — Somfit D (August 28, 2025)
  • K242447 — Falcon HST (February 20, 2025)
  • K231546 — Somfit (November 30, 2023)
  • K230073 — Okti (February 9, 2023)
  • K191785 — Orion LifeSpan MEG (February 14, 2020)
  • K093223 — COMPUMEDICS GRAEL SYSTEM, MODELS: GRAEL, GRAEL ECG (January 15, 2010)
  • K072201 — COMPUMEDICS SOMTE PSG RECORDING SYSTEM (April 14, 2008)
  • K003175 — COMPUMEDICS SIESTA SYSTEM (December 27, 2000)

Other clearances for product code MNR

  • K252497 — SANSA HSAT (December 10, 2025)
  • 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)