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 Ventilatory Effort Recorder
510(k) Number K020312
Device Name ULTIMA SNORING MIKE, MODEL 0540
Applicant
Braebon Medical Corp.
120 Walgreen Dr. (Rr#3)
Suite #1
Carp, Ontario,  CA K0A 1L0
Applicant Contact RICHARD A BONATO
Correspondent
Braebon Medical Corp.
120 Walgreen Dr. (Rr#3)
Suite #1
Carp, Ontario,  CA K0A 1L0
Correspondent Contact RICHARD A BONATO
Regulation Number868.2375
Classification Product Code
MNR  
Date Received01/30/2002
Decision Date 08/07/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-