Smart One 510(k) FDA Premarket Notification K181666 MIR Medical International Research

Device ID	K181666
510k Number	K181666
Device Name:	Smart One
Classification	Meter, Peak Flow, Spirometry
Applicant	MIR Medical International Research Via Del Maggiolino, 125 Roma, IT 00155
Contact	Gerda Van Houts
Correspondent	Dave Yungvirt THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren, NJ 07059
Product Code	BZH
CFR Regulation Number	868.1860 [🔎]
Decision	Substantially Equivalent (SESE)
Type	Traditional
3rd Party Reviewed	Yes
Combination Product	No
Date Received	2018-06-25
Decision Date	2018-08-01
Summary:	summary

Device Identifier	submissionNumber	Supplement
08052990321728	K181666	000
08052990321681	K181666	000

Mark Image Registration \| Serial	Company Trademark Application Date
SMART ONE 87280980 not registered Dead/Abandoned	Ahmed, Kazi K 2016-12-26
SMART ONE 85971773 4696681 Live/Registered	Peter D. Koleoglou 2013-06-27
SMART ONE 77957427 not registered Dead/Abandoned	Peter D. Koleoglou 2010-03-12
SMART ONE 77922606 not registered Dead/Abandoned	Peter D. Koleoglou 2010-01-28
SMART ONE 77916022 not registered Dead/Abandoned	Peter D. Koleoglou 2010-01-20
SMART ONE 77874610 4077517 Live/Registered	Peter D. Koleoglou 2009-11-17
SMART ONE 77594822 not registered Dead/Abandoned	Georgia-Pacific Sarl 2008-10-17
SMART ONE 76547184 2926231 Live/Registered	MOORECO, INC. 2003-09-26
SMART ONE 75672794 2370585 Live/Registered	Buckeye International, Inc. 1999-04-01
SMART ONE 75563046 not registered Dead/Abandoned	Sherwin-Williams Company, The 1998-10-02
SMART ONE 75233466 not registered Dead/Abandoned	Smart Brassieres Inc. 1997-01-30
SMART ONE 75071041 2153315 Live/Registered	Best Data Products, Inc. 1996-03-12

Smart One