The following data is part of a premarket notification filed by Qrs Diagnostic, Llc. with the FDA for Spirocard.
Device ID | K973138 |
510k Number | K973138 |
Device Name: | SPIROCARD |
Classification | Spirometer, Diagnostic |
Applicant | QRS DIAGNOSTIC, LLC. 14030 23RD AVE. NORTH Plymouth, MN 55447 |
Contact | Kevin J Driscoll |
Correspondent | Kevin J Driscoll QRS DIAGNOSTIC, LLC. 14030 23RD AVE. NORTH Plymouth, MN 55447 |
Product Code | BZG |
CFR Regulation Number | 868.1840 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-08-21 |
Decision Date | 1998-10-28 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SPIROCARD 77589652 3622676 Dead/Cancelled |
VECTRACOR, INC. 2008-10-09 |
SPIROCARD 75199930 2223125 Dead/Cancelled |
QRS DIAGNOSTIC, LLC 1996-11-19 |