FDA-Device2019-10-23Class II
Cerelink ICP Monitor, Model Number 826820; intended for use as an interface between compatible strain-gauge type pressure transducers and standard physiological pressure monitoring systems.
Integra LifeSciences Corp.
Hazard
There is a potential for a progressive decline in observed ICP readings of the monitor during use.
Sold states
The products were distributed to the following US states: CA, CO, CT, FL, IN, NY, OK, PA, TX, WI, and WV. The products were distributed to the following foreign countries: Australia, Belgium.
Affected count
189
Manufactured in
311 Enterprise Dr, N/A, Plainsboro, NJ, United States
Products
Cerelink ICP Monitor, Model Number 826820; intended for use as an interface between compatible strain-gauge type pressure transducers and standard physiological pressure monitoring systems.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0124-2020Don't want to check this manually?
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