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510(k) K120635

EASYONE PRO RESPIRATORY TESTING DEVICE by Ndd Medizitechnik AG — Product Code BTY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 2012
Date Received
March 1, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calculator, Predicted Values, Pulmonary Function
Device Class
Class II
Regulation Number
868.1890
Review Panel
AN
Submission Type

Other clearances by Ndd Medizitechnik AG

  • K091428 — EASYONE PRO RESPIRATORY ANALYSIS SYSTEM (January 27, 2010)
  • K090034 — EASY ON-PC SPIROMETER (June 2, 2009)

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  • K161534 — EasyOne Pro Respiratory Analysis System (February 22, 2017)