• 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 Ventilatory Effort Recorder
510(k) Number K122516
Device Name EMBLETTA MPR
Applicant
EMBLA SYSTEMS
1 HINES RD STE 202
KANATA,  CA K2K 3C7
Applicant Contact Jennifer Armstrong
Correspondent
EMBLA SYSTEMS
1 HINES RD STE 202
KANATA,  CA K2K 3C7
Correspondent Contact Jennifer Armstrong
Regulation Number868.2375
Classification Product Code
MNR  
Date Received08/17/2012
Decision Date 02/21/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-