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510(k) K093174

SPIROPALM by Cosmed Srl — Product Code BZG

K093174 is an FDA 510(k) premarket notification submitted by Cosmed Srl for the device "SPIROPALM". The FDA issued a decision of Substantially Equivalent on February 26, 2010. The device falls under product code BZG (Spirometer, Diagnostic), a Class II device regulated under 21 CFR 868.1840. Cosmed Srl has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 26, 2010
Date Received
October 8, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spirometer, Diagnostic
Device Class
Class II
Regulation Number
868.1840
Review Panel
AN
Submission Type

Other clearances by Cosmed Srl

  • K190800 — Cosmed Q-NRG / Q-NRG+ Portable Metabolic Monitors (February 6, 2020)
  • K162515 — COSMED K5 Wearable Metabolic Technology (June 20, 2017)
  • K120146 — QUARK SERIES (December 11, 2012)
  • K071533 — FITMATE SERIES (September 28, 2007)
  • K040549 — COSMED PONY FX (September 28, 2004)
  • K020745 — COSMED MICROQUARK (January 2, 2003)
  • K014262 — COSMED QUARK C12/QUARK T12 (March 26, 2002)
  • K001174 — COSMED QUARK (January 11, 2001)
  • K963373 — COSMED K4 (September 10, 1997)

Other clearances for product code BZG

  • K251777 — MESI mTABLET SPIRO (March 2, 2026)
  • K241843 — TD-7301 Spirometer (TD-7301) (November 20, 2024)
  • K231416 — Air Next (NVD-02) (January 18, 2024)
  • K230501 — Spirobank Oxi (December 15, 2023)
  • K230178 — EasyOne Sky Spirometer (October 19, 2023)
  • K222525 — Alveoair Digital Spirometer (August 28, 2023)
  • K222443 — Air Smart Extra Spirometer (August 9, 2023)
  • K213754 — SpiroHome Personal, SpiroHome Clinic (June 12, 2023)
  • K213872 — ComPAS2 (July 15, 2022)
  • K212938 — Vitalograph Model 6000 Alpha (January 26, 2022)

FDA data resources