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510(k) K110810

ANASCIENT BREATH MONITOR by Invoy Technologies, LLC — Product Code BZL

K110810 is an FDA 510(k) premarket notification submitted by Invoy Technologies, LLC for the device "ANASCIENT BREATH MONITOR". The FDA issued a decision of Substantially Equivalent on June 21, 2011. 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
June 21, 2011
Date Received
March 23, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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)
  • K190561 — NICU V'02 (September 4, 2020)
  • 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