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 set, tubing and support, ventilator (w harness)
510(k) Number K893760
Device Name CRITERION I.V. VENTILATOR BREATHING CIRCUIT #1004
Applicant
NOVA-VENTRX
4309 REGENCY DR.
WHEELING,  IL  60025
Applicant Contact BERNARD R PALUCH
Correspondent
NOVA-VENTRX
4309 REGENCY DR.
WHEELING,  IL  60025
Correspondent Contact BERNARD R PALUCH
Regulation Number868.5975
Classification Product Code
BZO  
Date Received05/19/1989
Decision Date 08/10/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-