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510(k) K240293

STS by Techbopulm, Ltd. — Product Code BZC

K240293 is an FDA 510(k) premarket notification submitted by Techbopulm, Ltd. for the device "STS". The FDA issued a decision of Substantially Equivalent on September 17, 2024. The device falls under product code BZC (Calculator, Pulmonary Function Data), a Class II device regulated under 21 CFR 868.1880.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 17, 2024
Date Received
February 1, 2024
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

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  • 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)
  • K161295 — MiniBox + (October 21, 2016)
  • 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)

FDA data resources