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, I.V. Fluid Transfer
510(k) Number K920015
Device Name QUICKTEST SYSTEM
Applicant
Q.I. Medical, Inc.
C/O Hedman & Associates
349 Brock Rd.
Nevada City,  CA  95959
Applicant Contact HILARY R HEDMAN
Correspondent
Q.I. Medical, Inc.
C/O Hedman & Associates
349 Brock Rd.
Nevada City,  CA  95959
Correspondent Contact HILARY R HEDMAN
Regulation Number880.5440
Classification Product Code
LHI  
Date Received01/02/1992
Decision Date 11/23/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-