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510(k) K213872

ComPAS2 by Morgan Scientific, Inc. — Product Code BZG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 15, 2022
Date Received
December 13, 2021
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 Morgan Scientific, Inc.

  • K190568 — ComPAS2 (Computerized Pulmonary Analysis System) (June 6, 2019)
  • K042595 — SPIRO'AIR (May 4, 2005)
  • K022636 — BODY BOX 5500 (January 13, 2003)
  • K021200 — COMPAS (October 18, 2002)
  • K013752 — COMPAS AS (COMPUTERIZED PULMONARY ANALYSIS SYSTEM) (January 30, 2002)

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)
  • K212938 — Vitalograph Model 6000 Alpha (January 26, 2022)
  • K201493 — Spirometer (June 10, 2021)