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510(k) K190561

NICU V'02 by Cosmed Nordic Aps — Product Code BZL

K190561 is an FDA 510(k) premarket notification submitted by Cosmed Nordic Aps for the device "NICU V'02". The FDA issued a decision of Substantially Equivalent on September 4, 2020. The device falls under product code BZL (Computer, Oxygen-Uptake), a Class II device regulated under 21 CFR 868.1730.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 4, 2020
Date Received
March 5, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Computer, Oxygen-Uptake
Device Class
Class II
Regulation Number
868.1730
Review Panel
AN
Submission Type

Other clearances for product code BZL

  • K200076 — Breezing Med (September 25, 2020)
  • K110810 — ANASCIENT BREATH MONITOR (June 21, 2011)
  • K093080 — METAPHOR METABOLIC MONITOR (January 22, 2010)
  • K071533 — FITMATE SERIES (September 28, 2007)
  • K070858 — EXPRESS SERIES (April 16, 2007)
  • K061731 — MEDGRAPHICS ULTIMA SYSTEM (September 6, 2006)
  • K021490 — REEVUE INDIRECT CALORIMETER, MODEL#8100 (January 2, 2003)
  • K021605 — MEDGEM (June 14, 2002)
  • K010577 — BODYGEM, MODEL HB211 (January 10, 2002)
  • K954731 — OXYLOG 2 (January 6, 1997)

FDA data resources