FDA-Device2018-08-29Class II

O-Two Equinox¿ Relieve N2O/O2 Analgesic Gas Mixing and Delivery System Model#: 01EQ1000

O-Two Medical Technologies, Inc.
Hazard

Higher levels of nitrous oxide delivered than specification

Sold states
AK, CA, FL
Affected count
3 units
Manufactured in
7575 Kimbel Street, Mississauga, Canada
Products
O-Two Equinox¿ Relieve N2O/O2 Analgesic Gas Mixing and Delivery System Model#: 01EQ1000

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2885-2018

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