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 K946322
Device Name POLYGRAM SOFTWARE
Applicant
Synectics Medical, Inc.
Renstienas Gata 12, 5tr.
S-116 28 Stockholm,  SE S-11628
Applicant Contact ANNA PETTERSON
Correspondent
Synectics Medical, Inc.
Renstienas Gata 12, 5tr.
S-116 28 Stockholm,  SE S-11628
Correspondent Contact ANNA PETTERSON
Regulation Number868.1840
Classification Product Code
BZG  
Date Received12/28/1994
Decision Date 07/07/1995
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
-
-