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 Insufflator, Laparoscopic
510(k) Number K905417
Device Name ELMED PNEUMOMAT DIGITAL
Applicant
ELMED, INC.
60 WEST FAY AVE.
ADDISON,  IL  60101
Applicant Contact KARL HAUSNER
Correspondent
ELMED, INC.
60 WEST FAY AVE.
ADDISON,  IL  60101
Correspondent Contact KARL HAUSNER
Regulation Number884.1730
Classification Product Code
HIF  
Date Received12/04/1990
Decision Date 01/31/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-