510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K252923Substantially Equivalent

IASIS i2 Relaxation Neurofeedback System

Iasis Technologies, Murrieta CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K252923 is the FDA 510(k) clearance record for IASIS i2 Relaxation Neurofeedback System, cleared for Iasis Technologies on . FDA records list one 510(k) clearance for Iasis Technologies. As of , FDA records show no recalls naming K252923.

Clearance record

Decision date
Received
(179 days to decision)
Review panel
Unknown
Applicant
Iasis Technologies 38975 Sky Canyon Dr. #105, Murrieta CA
510(k) summary
Summary PDF
Third party review
No