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 K843681
Device Name RESPIRATION & HEART RATE MONITOR 530
Applicant
TRI-MED, INC.
10301 WILLOWS RD.
REDMOND,  WA  98005
Applicant Contact BERT POST
Correspondent
TRI-MED, INC.
10301 WILLOWS RD.
REDMOND,  WA  98005
Correspondent Contact BERT POST
Regulation Number868.2375
Classification Product Code
BZQ  
Date Received09/18/1984
Decision Date 12/04/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-