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510(k) K133051

PULMONE MINIBOX PFT TM by Pulmone Advanced Medical Devices, Ltd. — Product Code BZC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 2014
Date Received
September 27, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calculator, Pulmonary Function Data
Device Class
Class II
Regulation Number
868.1880
Review Panel
AN
Submission Type

Other clearances by Pulmone Advanced Medical Devices, Ltd.

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  • K141793 — PULMONE MINIBOXPFT 2.0 (March 6, 2015)

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  • K181524 — Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable (November 30, 2018)
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  • K161295 — MiniBox + (October 21, 2016)
  • K150810 — Vyntus / SentrySuite Product Line (August 14, 2015)
  • K133925 — VYNTUS/ SENTRYSUITE PRODUCT LINE (August 22, 2014)
  • K102047 — LCI OPTION FOR INNOCOR (November 1, 2011)
  • K072323 — MASTERSCREEN & OXYCON CPX (October 10, 2007)