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510(k) K141793

PULMONE MINIBOXPFT 2.0 by Pulmone Advanced Medical Devices, Ltd. — Product Code BZG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 6, 2015
Date Received
July 2, 2014
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 Pulmone Advanced Medical Devices, Ltd.

  • K161295 — MiniBox + (October 21, 2016)
  • K133051 — PULMONE MINIBOX PFT TM (May 2, 2014)

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