Pulmone Minibox PFT TM

FDA 510(k) K133051 · Pulmone Advanced Medical Devices, Ltd.

Substantially Equivalent

510(k) numberK133051

Submission

Device name
Pulmone Minibox PFT TM
Applicant
Pulmone Advanced Medical Devices, Ltd.
Gaithersburg, MD, US
Received
September 27, 2013
Decision date
May 2, 2014
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
BZC – Calculator, Pulmonary Function Data
Device class
Class II (moderate risk)
Regulation
21 CFR 868.1880
Specialty
Anesthesiology

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Questions and answers

When was Pulmone Minibox PFT TM cleared by the FDA?

Pulmone Minibox PFT TM (K133051) received a 510(k) decision of Substantially Equivalent on May 2, 2014, 217 days after the submission was received.

What is the product code of K133051?

The FDA product code is BZC – Calculator, Pulmonary Function Data, a Class II (moderate risk) device regulated under 21 CFR 868.1880.