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 ventilator, non-continuous (respirator)
510(k) Number K934804
Device Name PURITAN-BENNETT COMPANION 320 I/E
Applicant
PURITAN BENNETT CORP.
10800 PFLUMM RD.
LENEXA,  KS  66215
Applicant Contact C. MARSHALL SMITH
Correspondent
PURITAN BENNETT CORP.
10800 PFLUMM RD.
LENEXA,  KS  66215
Correspondent Contact C. MARSHALL SMITH
Regulation Number868.5905
Classification Product Code
BZD  
Date Received10/07/1993
Decision Date 02/27/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-