FDA-Device2020-07-15Class II
FHC Guideline 4000 5.0 GL5 Main Processing Unit - Product Usage: intended to record and stimulate electrophysiological activity, as well as aid in the accurate placement of electrodes and other instruments. Catalogue Number: C0215 UDI: 00873263006740
FHC, Inc.
Hazard
An electrical sub-circuit was not properly connected. Its purpose is to eliminate the possibility of interference with proper performance of the Guideline 5 Main Processing Unit, if an ESD event (greater than 6kV) were to occur.
Sold states
US Nationwide distribution including in the states of CA, NC, TN, TX, WA.
Affected count
6 units
Manufactured in
1201 Main St, Bowdoin, ME, United States
Products
FHC Guideline 4000 5.0 GL5 Main Processing Unit - Product Usage: intended to record and stimulate electrophysiological activity, as well as aid in the accurate placement of electrodes and other instruments. Catalogue Number: C0215 UDI: 00873263006740
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2540-2020Don't want to check this manually?
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