Home / 510(k) Clearances / K113096

510(k) K113096

MICRO I by Carefusion Germany 234 GmbH — Product Code BZG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 13, 2012
Date Received
October 19, 2011
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 Carefusion Germany 234 GmbH

  • K153654 — Sentry WEB SmartInterp (September 16, 2016)
  • K150810 — Vyntus / SentrySuite Product Line (August 14, 2015)
  • K142959 — Vyntus Walk (March 20, 2015)
  • K141936 — MICROBLAB, MICROLOOP (December 29, 2014)
  • K133925 — VYNTUS/ SENTRYSUITE PRODUCT LINE (August 22, 2014)
  • K122699 — SENTRYSUITE PRODUCT LINE (November 19, 2012)
  • K113813 — SENTRYSUITE PRODUCT LINE (May 10, 2012)
  • K111408 — MICROGARD II (October 17, 2011)
  • K111053 — SENTRYSUITE PRODUCT LINE (August 12, 2011)
  • K101873 — MASTERSCREEN IOS (February 10, 2011)

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)