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510(k) K230178

EasyOne Sky Spirometer by Ndd Medizintechnik AG — Product Code BZG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 19, 2023
Date Received
January 23, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spirometer, Diagnostic
Device Class
Class II
Regulation Number
868.1840
Review Panel
AN
Submission Type

Other clearances by Ndd Medizintechnik AG

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  • K161534 — EasyOne Pro Respiratory Analysis System (February 22, 2017)
  • K161536 — EasyOne Air Spirometer (January 5, 2017)

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  • K230501 — Spirobank Oxi (December 15, 2023)
  • K222525 — Alveoair Digital Spirometer (August 28, 2023)
  • K222443 — Air Smart Extra Spirometer (August 9, 2023)
  • K213754 — SpiroHome Personal, SpiroHome Clinic (June 12, 2023)
  • K213872 — ComPAS2 (July 15, 2022)
  • K212938 — Vitalograph Model 6000 Alpha (January 26, 2022)
  • K201493 — Spirometer (June 10, 2021)