Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Spirometer, Diagnostic
510(k) Number K001278
Device Name SENSAIRE DIAGNOSTIC SPIROMETER
Applicant
Qrs Diagnostic, LLC
14755 27th Ave.North
Plymouth,  MN  55447
Applicant Contact JILL R KRALL
Correspondent
Qrs Diagnostic, LLC
14755 27th Ave.North
Plymouth,  MN  55447
Correspondent Contact JILL R KRALL
Regulation Number868.1840
Classification Product Code
BZG  
Date Received04/21/2000
Decision Date 11/29/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-