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 K894641
Device Name MESAM RECORDER
Applicant
MADAUS MEDTEC, INC.
901 BETHLEHEM PIKE
SPRING HOUSE,  PA  19902
Applicant Contact MAHONY
Correspondent
MADAUS MEDTEC, INC.
901 BETHLEHEM PIKE
SPRING HOUSE,  PA  19902
Correspondent Contact MAHONY
Regulation Number868.2375
Classification Product Code
BZQ  
Date Received07/24/1989
Decision Date 01/22/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-