PULMONE MINIBOX PFT TM— 510(k) K133051

Substantially Equivalent

Pulmone Advanced Medical Devices, Ltd.

FDA 510(k) clearance K133051 for PULMONE MINIBOX PFT TM, Substantially Equivalent on 2014-05-02. Applicant: Pulmone Advanced Medical Devices, Ltd..

Clearance details

Applicant: Pulmone Advanced Medical Devices, Ltd.
Product code: Code BZC
Advisory panel: Anesthesiology
Date received: 2013-09-27
Decision date: 2014-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gaithersburg, MD, US

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