Monaco

System, Planning, Radiation Therapy Treatment

IMPAC MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Impac Medical Systems, Inc. with the FDA for Monaco.

Pre-market Notification Details

Device IDK151233
510k NumberK151233
Device Name:Monaco
ClassificationSystem, Planning, Radiation Therapy Treatment
Applicant IMPAC MEDICAL SYSTEMS, INC. 13723 Riverport Drive Suite 100 Maryland Heights,  MO  63043
ContactKathryn Stinson
CorrespondentKathryn Stinson
IMPAC MEDICAL SYSTEMS, INC. 13723 Riverport Drive Suite 100 Maryland Heights,  MO  63043
Product CodeMUJ  
CFR Regulation Number892.5050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-05-08
Decision Date2015-07-07
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00858164002190 K151233 000
00858164002183 K151233 000
00858164002169 K151233 000
00858164002152 K151233 000

Trademark Results [Monaco]

Mark Image

Registration | Serial
Company
Trademark
Application Date
MONACO
MONACO
97349117 not registered Live/Pending
REV Recreation Group, Inc.
2022-04-06
MONACO
MONACO
90024491 not registered Live/Pending
BUYS, JERRY
2020-06-28
MONACO
MONACO
90008594 not registered Live/Pending
Monaco Residential LP
2020-06-18
MONACO
MONACO
88907433 not registered Live/Pending
Monaco Natural Health Solutions LLC
2020-05-08
MONACO
MONACO
88700582 not registered Live/Pending
Yates Company, LLC
2019-11-20
MONACO
MONACO
88650958 not registered Live/Pending
BCI Burke Company, LLC
2019-10-11
MONACO
MONACO
88636179 not registered Live/Pending
Summit Wireless Technologies, Inc.
2019-09-30
MONACO
MONACO
88615506 not registered Live/Pending
Atomic Brands, Inc.
2019-09-13
MONACO
MONACO
88375704 not registered Live/Pending
Highwater Marine LLC
2019-04-08
MONACO
MONACO
88055195 not registered Dead/Abandoned
Aqua Monaco GmbH
2018-07-27
MONACO
MONACO
87516631 not registered Dead/Abandoned
R&N Ocean Partners Inc.
2017-07-05
MONACO
MONACO
87478514 5369841 Live/Registered
Safavieh Intl. LLC
2017-06-07

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