Atlas FDA

BIS INTERFACE FOR VITALOGIK PATIENT MONITORS

FDA 510(k) clearance K083063 · decided 2008-12-16

Clearance details

K-number
K083063
Device name
BIS INTERFACE FOR VITALOGIK PATIENT MONITORS
Applicant
Mennen Medical , Ltd.
Decision
Substantially Equivalent
Date received
2008-10-14
Decision date
2008-12-16
Days to decision
63 days
Clearance type
Traditional
Product code
OLW
Device class
2
Regulation number
882.1400
Medical specialty
Neurology
Advisory committee
Neurology
Location
Rohovot, IL
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.