SPIROCARD

Spirometer, Diagnostic

QRS DIAGNOSTIC, LLC.

The following data is part of a premarket notification filed by Qrs Diagnostic, Llc. with the FDA for Spirocard.

Pre-market Notification Details

Device IDK973138
510k NumberK973138
Device Name:SPIROCARD
ClassificationSpirometer, Diagnostic
Applicant QRS DIAGNOSTIC, LLC. 14030 23RD AVE. NORTH Plymouth,  MN  55447
ContactKevin J Driscoll
CorrespondentKevin J Driscoll
QRS DIAGNOSTIC, LLC. 14030 23RD AVE. NORTH Plymouth,  MN  55447
Product CodeBZG  
CFR Regulation Number868.1840 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-08-21
Decision Date1998-10-28
Summary:summary

Trademark Results [SPIROCARD]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SPIROCARD
SPIROCARD
77589652 3622676 Dead/Cancelled
VECTRACOR, INC.
2008-10-09
SPIROCARD
SPIROCARD
75199930 2223125 Dead/Cancelled
QRS DIAGNOSTIC, LLC
1996-11-19

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.