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 K982137
Device Name BLEASE FRONTLINE GENIUS RANGE ANAESTHESIA MACHINE
Applicant
BLEASE MEDICAL EQUIPMENT LTD.
12601 RESEARCH PKWY.
ATT: FRANCIS X CASEY
ORLANDO,  FL  32826
Applicant Contact FRANCIS X CASEY
Correspondent
BLEASE MEDICAL EQUIPMENT LTD.
12601 RESEARCH PKWY.
ATT: FRANCIS X CASEY
ORLANDO,  FL  32826
Correspondent Contact FRANCIS X CASEY
Regulation Number868.5160
Classification Product Code
BSZ  
Date Received06/17/1998
Decision Date 04/09/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-