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 K934669
Device Name ARC
Applicant
Medelec , Ltd.
Manor Way
Old Woking
Surrey, England Gu22 9ju,  GB
Applicant Contact J B HOLLOWAY
Correspondent
Medelec , Ltd.
Manor Way
Old Woking
Surrey, England Gu22 9ju,  GB
Correspondent Contact J B HOLLOWAY
Regulation Number868.5160
Classification Product Code
BSZ  
Date Received09/29/1993
Decision Date 04/26/1994
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
-
-