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510(k) K201562

Spirotrac by Vitalograph Ireland, Ltd. — Product Code BZG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 14, 2020
Date Received
June 10, 2020
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 Vitalograph Ireland, Ltd.

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  • K221030 — Model 9100 PFT/DICO (July 15, 2022)
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  • K200550 — Vitalograph Model 2120 In2itive eDiary (July 27, 2020)

Other clearances for product code BZG

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  • K241843 — TD-7301 Spirometer (TD-7301) (November 20, 2024)
  • K231416 — Air Next (NVD-02) (January 18, 2024)
  • K230501 — Spirobank Oxi (December 15, 2023)
  • K230178 — EasyOne Sky Spirometer (October 19, 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)