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 Condenser, Heat And Moisture (Artificial Nose)
510(k) Number K952845
Device Name HUMID-VENT TRACH-VENT
Applicant
GIBECK, INC.
10640 EAST 59TH ST.
P.O. BOX 36430
INDIANAPOLIS,  IN  46236
Applicant Contact BRIAN GRIGSBY
Correspondent
GIBECK, INC.
10640 EAST 59TH ST.
P.O. BOX 36430
INDIANAPOLIS,  IN  46236
Correspondent Contact BRIAN GRIGSBY
Regulation Number868.5375
Classification Product Code
BYD  
Date Received06/21/1995
Decision Date 07/25/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-