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 apparatus, autotransfusion
510(k) Number K955010
Device Name AUTOVAC BP SYSTE, 2000 SERIES
Applicant
BOEHRINGER LABORATORIES
500 E. WASHINGTON ST.
NORRISTOWN,  PA  19401
Applicant Contact JOHN KARPOWICZ
Correspondent
BOEHRINGER LABORATORIES
500 E. WASHINGTON ST.
NORRISTOWN,  PA  19401
Correspondent Contact JOHN KARPOWICZ
Regulation Number868.5830
Classification Product Code
CAC  
Date Received11/01/1995
Decision Date 06/20/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-