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510(k) K161295

MiniBox + by Pulmone Advanced Medical Devices, Ltd. — Product Code BZC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 21, 2016
Date Received
May 9, 2016
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.

  • K141793 — PULMONE MINIBOXPFT 2.0 (March 6, 2015)
  • K133051 — PULMONE MINIBOX PFT TM (May 2, 2014)

Other clearances for product code BZC

  • K240293 — STS (September 17, 2024)
  • K183567 — Vyntus/SentrySuite Product Line (August 23, 2019)
  • K190853 — Vyntus BODY (August 16, 2019)
  • K181524 — Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable (November 30, 2018)
  • K162515 — COSMED K5 Wearable Metabolic Technology (June 20, 2017)
  • K150810 — Vyntus / SentrySuite Product Line (August 14, 2015)
  • K133925 — VYNTUS/ SENTRYSUITE PRODUCT LINE (August 22, 2014)
  • K133051 — PULMONE MINIBOX PFT TM (May 2, 2014)
  • K102047 — LCI OPTION FOR INNOCOR (November 1, 2011)
  • K072323 — MASTERSCREEN & OXYCON CPX (October 10, 2007)