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 K923737
Device Name MODEL MEDILOG RAPIDE
Applicant
OXFORD MEDILOG, INC.
11526 53RD. ST. N.
CLEARWATER,  FL  33520
Applicant Contact CHARLES HOLZ
Correspondent
OXFORD MEDILOG, INC.
11526 53RD. ST. N.
CLEARWATER,  FL  33520
Correspondent Contact CHARLES HOLZ
Regulation Number868.2375
Classification Product Code
BZQ  
Date Received07/27/1992
Decision Date 01/05/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-