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 ventilator, non-continuous (respirator)
510(k) Number K012207
Device Name ADVANTAGE NASAL MASK, SMALL, ADVANTAGE NASAL MASK. REGULAR, MODELS TMS-2520, TMS 2530
Applicant
TIARA MEDICAL SYSTEMS, INC.
14414 DETROIT AVE, SUITE 205
LAKEWOOD,  OH  44107
Applicant Contact GEOFFREY SLEEPER
Correspondent
TIARA MEDICAL SYSTEMS, INC.
14414 DETROIT AVE, SUITE 205
LAKEWOOD,  OH  44107
Correspondent Contact GEOFFREY SLEEPER
Regulation Number868.5905
Classification Product Code
BZD  
Date Received07/16/2001
Decision Date 07/23/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
-
-