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 Calculator, Predicted Values, Pulmonary Function
510(k) Number K850045
Device Name SPIROMETRICS 2453 & SMI III
Applicant
Spirometrics, Inc.
26 Essex St.
Andover,  MA  01810
Applicant Contact NOEL G WRAY
Correspondent
Spirometrics, Inc.
26 Essex St.
Andover,  MA  01810
Correspondent Contact NOEL G WRAY
Regulation Number868.1890
Classification Product Code
BTY  
Date Received01/07/1985
Decision Date 02/14/1985
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
-
-