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510(k) K152585

Resmon PRO FULL by Medical Graphics Corp. — Product Code PNV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 2016
Date Received
September 10, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Impedance Measuring Device Utilizing Oscillation Techniques
Device Class
Class II
Regulation Number
868.1840
Review Panel
AN
Submission Type

This device measures respiratory impedance.

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  • K943259 — 1085 ULTIMATE E PLETHYSMOGRAPH (April 10, 1995)
  • K923209 — MEDGRAPHICS EXERCISE CONSULT (March 11, 1993)
  • K912906 — MEDGRAPHICS PF/DX (February 4, 1992)
  • K896345 — EXERCISE EVALUATION SYSTEM 2010 (January 20, 1990)
  • K896396 — MIDA SYSTEM, MODELS 1000/1100 (January 18, 1990)
  • K874925 — CPE 2000 CARDIO PULMONARY ERGOMETER (January 19, 1988)
  • K871711 — MEDICAL GRAPHICS DESKTOP DIAGNOSTIC SYSTEM (September 25, 1987)

Other clearances for product code PNV

  • K221024 — tremoflo C2 Airwave Oscillometry System (June 20, 2023)
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  • K170185 — tremoFlo C-100 Airwave Oscillometry System (September 12, 2017)