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 Syringe, Piston
510(k) Number K102192
Device Name INDISCAL DIGITAL MANOMETER
Applicant
Baylis Medical Co., Inc.
2645 Matheson Blvd. E.
Mississauga, Ontario,  CA L4W 5S4
Applicant Contact MEGHAL KHAKHAR
Correspondent
Baylis Medical Co., Inc.
2645 Matheson Blvd. E.
Mississauga, Ontario,  CA L4W 5S4
Correspondent Contact MEGHAL KHAKHAR
Regulation Number880.5860
Classification Product Code
FMF  
Date Received08/04/2010
Decision Date 02/23/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-