SANDMAN POCKET

Ventilatory Effort Recorder

EB NEURO, S.P.A.

The following data is part of a premarket notification filed by Eb Neuro, S.p.a. with the FDA for Sandman Pocket.

Pre-market Notification Details

Device IDK061996
510k NumberK061996
Device Name:SANDMAN POCKET
ClassificationVentilatory Effort Recorder
Applicant EB NEURO, S.P.A. 11460 N. MERIDIAN ST. SUITE 150 Carmel,  IN  46032
ContactCarri Graham
CorrespondentMark Job
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeMNR  
CFR Regulation Number868.2375 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2006-07-14
Decision Date2006-10-03
Summary:summary

Trademark Results [SANDMAN POCKET]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SANDMAN POCKET
SANDMAN POCKET
78597287 not registered Dead/Abandoned
Nellcor Puritan Bennett Incorporated
2005-03-29

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