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 Monitor, Breathing Frequency
510(k) Number K842048
Device Name SUN-ONE
Applicant
Ensun Medical Products, Inc.
10011 W. Gulf Bank
Houston,  TX  77040
Applicant Contact ALLEN KEARNS
Correspondent
Ensun Medical Products, Inc.
10011 W. Gulf Bank
Houston,  TX  77040
Correspondent Contact ALLEN KEARNS
Regulation Number868.2375
Classification Product Code
BZQ  
Date Received05/22/1984
Decision Date 11/01/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-