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 Gas-Machine, Anesthesia
510(k) Number K052335
Device Name ANALGESIA GAS MACHINE, MODEL DIGITAL ULTRA
Applicant
ACCUTRON, INC.
13605 WEST 7TH AVENUE
GOLDEN,  CO  80401 -4604
Applicant Contact ROBERT N CLARK
Correspondent
ACCUTRON, INC.
13605 WEST 7TH AVENUE
GOLDEN,  CO  80401 -4604
Correspondent Contact ROBERT N CLARK
Regulation Number868.5160
Classification Product Code
BSZ  
Date Received08/26/2005
Decision Date 11/23/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-