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 K072979
Device Name SPIROBANK G
Applicant
Mir Medical Intl. Research Srl
Via Del Maggiolino, 125
Roma,  IT 00155
Applicant Contact SIMON FOWLER
Correspondent
Mir Medical Intl. Research Srl
Via Del Maggiolino, 125
Roma,  IT 00155
Correspondent Contact SIMON FOWLER
Regulation Number868.1840
Classification Product Code
BZG  
Date Received10/22/2007
Decision Date 12/26/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-