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510(k) K141936

MICROBLAB, MICROLOOP by Carefusion Germany 234 GmbH — Product Code BZG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 29, 2014
Date Received
July 17, 2014
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

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  • K133925 — VYNTUS/ SENTRYSUITE PRODUCT LINE (August 22, 2014)
  • K122699 — SENTRYSUITE PRODUCT LINE (November 19, 2012)
  • K113813 — SENTRYSUITE PRODUCT LINE (May 10, 2012)
  • K113096 — MICRO I (April 13, 2012)
  • K111408 — MICROGARD II (October 17, 2011)
  • K111053 — SENTRYSUITE PRODUCT LINE (August 12, 2011)
  • K101873 — MASTERSCREEN IOS (February 10, 2011)

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